A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified pro...
FDA Device Recall #Z-0612-2018 — Class II — July 27, 2017
Recall Summary
| Recall Number | Z-0612-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 27, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Zimmer Surgical Inc |
| Location | Dover, OH |
| Product Type | Devices |
| Quantity | 8,231 devices total |
Product Description
A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. .
Reason for Recall
Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment.
Distribution Pattern
Worldwide Distribution: US (nationwide) to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Guam; and countries to Australia, Brazil, Canada, Chile, China, Denmark, Dominican, El Salvador, England, Finland, France, Hong Kong, India, Italy, Japan, Malaysia, Mexico, Netherlands, Panama, Singapore, Sweden, Taiwan, and Thailand..
Lot / Code Information
Item No. 60400040400, Lot No. 62510549 (Serial Numbers: 4013JAAA, 4013JAAB, 4013JAAC, 4013JAAD, 4013JAAE, 4013JAAF, 4013JAAG, 4013JAAH, 4013JAAJ, 4013JAAK, 4013JAAL, 4013JAAM, 4013JAAN, 4013JAAP, 4013JAAQ, 4013JAAR, 4013JAAS, 4013JAAT, 4013JAAU, 4013JAAW, 4013JABA, 4013JABB, 4013JABC, 4013JABD, 4013JABE, 4013JABF, 4013JABG); Lot No. 62510845 (Serial Numbers: 4013JABH, 4013JABJ, 4013JABK, 4013JABL, 4013JABM, 4013JABN, 4013JABP, 4013JABQ, 4013JABR, 4013JABS, 4013JABT, 4013JABU, 4013JABW, 4013JACA, 4013JACB, 4013JACC, 4013JACD, 4013JACE, 4013JACF, 4013JACG); Lot No. 62510927 (Serial Numbers: 4013JACH, 4013JACJ, 4013JACK, 4013JACL, 4013JACM, 4013JACN, 4013JACP, 4013JACQ, 4013JACR, 4013JACS, 4013JACT, 4013JACU, 4013JACW, 4013JADA, 4013JADB, 4013JADC, 4013JADD, 4013JADE, 4013JADF, 4013JADG); Lot No. 62510928 (Serial Numbers: 4013JADH, 4013JADJ, 4013JADK, 4013JADL, 4013JADM, 4013JADN, 4013JADP, 4013JADQ, 4013JADR, 4013JADS, 4013JADT, 4013JADU, 4013JADW, 4013JAEA, 4013JAEB, 4013JAEC, 4013JAED, 4013JAEE, 4013JAEF, 4013JAEG); Lot No. 62525817 (Serial Numbers: 4013KAAA, 4013KAAB, 4013KAAC, 4013KAAD, 4013KAAE, 4013KAAF, 4013KAAG, 4013KAAH, 4013KAAJ, 4013KAAK, 4013KAAL, 4013KAAM, 4013KAAN, 4013KAAP, 4013KAAQ, 4013KAAR, 4013KAAS, 4013KAAT, 4013KAAU, 4013KAAW); Lot No. 62525841 (Serial Numbers: 4013KABA, 4013KABB, 4013KABC, 4013KABD, 4013KABE, 4013KABF, 4013KABG, 4013KABH, 4013KABJ, 4013KABK, 4013KABL, 4013KABM, 4013KABN, 4013KABP, 4013KABQ, 4013KABR, 4013KABS, 4013KABT, 4013KABU, 4013KABW); Lot No. 62616141 (Serial Numbers: 4014BAAA, 4014BAAB, 4014BAAC, 4014BAAD, 4014BAAE, 4014BAAF, 4014BAAG, 4014BAAH, 4014BAAJ, 4014BAAK, 4014BAAL, 4014BAAM, 4014BAAN, 4014BAAP, 4014BAAQ, 4014BAAR, 4014BAAS, 4014BAAT, 4014BAAU, 4014BAAW); Lot No. 62616142 (Serial Numbers: 4014BABA, 4014BABB, 4014BABC, 4014BABD, 4014BABE, 4014BABF, 4014BABG, 4014BABH, 4014BABJ, 4014BABK, 4014BABL, 4014BABM, 4014BABN, 4014BABP, 4014BABQ, 4014BABR, 4014BABS, 4014BABT, 4014BABU, 4014BABW); Lot No. 62616143 (Serial Numbers: 4014BACA, 4014BACB, 4014BACC, 4014BACD, 4014BACE, 4014BACF, 4014BACG, 4014BACH, 4014BACJ, 4014BACK, 4014BACL, 4014BACM, 4014BACN, 4014BACP, 4014BACQ, 4014BACR, 4014BACS, 4014BACT, 4014BACU, 4014BACW); Lot No. 62616145 (Serial Number: 4014BADA, 4014BADB, 4014BADC, 4014BADD, 4014BADE, 4014BADF, 4014BADG, 4014BADH, 4014BADJ, 4014BADK, 4014BADL, 4014BADM, 4014BADN, 4014BADP, 4014BADQ, 4014BADR, 4014BADS, 4014BADT, 4014BADU, 4014BADW): Lot No. 62635795 (Serial Numbers: 4014CAAA, 4014CAAB, 4014CAAC, 4014CAAD, 4014CAAE, 4014CAAF, 4014CAAG, 4014CAAH, 4014CAAJ, 4014CAAK, 4014CAAL, 4014CAAM, 4014CAAN, 4014CAAP, 4014CAAQ, 4014CAAR, 4014CAAS, 4014CAAT, 4014CAAU, 4014CAAW); Lot No. 62635796 (Serial Numbers: 4014CABA, 4014CABB, 4014CABC, 4014CABD, 4014CABE, 4014CABF, 4014CABG, 4014CABH, 4014CABJ, 4014CABK, 4014CABL, 4014CABM, 4014CABN, 4014CABP, 4014CABQ, 4014CABR, 4014CABS, 4014CABT, 4014CABU, 4014CABW); Lot No. 62635797 (Serial Numbers: 4014CACA, 4014CACB, 4014CACC, 4014CACD, 4014CACE, 4014CACF, 4014CACG, 4014CACH, 4014CACJ, 4014CACK, 4014CACL, 4014CACM, 4014CACN, 4014CACP, 4014CACQ, 4014CACR, 4014CACS, 4014CACT, 4014CACU, 4014CACW); Lot No. 62642282 (Serial Numbers: 4014CADA, 4014CADB, 4014CADC, 4014CADD, 4014CADE, 4014CADF, 4014CADG, 4014CADH, 4014CADJ, 4014CADK, 4014CADL, 4014CADM, 4014CADN, 4014CADP, 4014CADQ, 4014CADR, 4014CADS, 4014CADT,4014CADU, 4014CADW); Lot No. 62635798 (Serial Numbers: 4014CAEA, 4014CAEB, 4014CAEC, 4014CAED, 4014CAEE, 4014CAEF, 4014CAEG, 4014CAEH, 4014CAEJ, 4014CAEK, 4014CAEL, 4014CAEM, 4014CAEN, 4014CAEP, 4014CAEQ, 4014CAER, 4014CAES, 4014CAET, 4014CAEU, 4014CAEW); Lot No. 62676173 (Serial Numbers: 4014DAAA, 4014DAAB, 4014DAAC, 4014DAAD, 4014DAAE, 4014DAAF, 4014DAAG, 4014DAAH, 4014DAAJ, 4014DAAK, 4014DAAL, 4014DAAM, 4014DAAN, 4014DAAP, 4014DAAQ, 4014DAAR, 4014DAAS, 4014DAAT, 4014DAAU, 4014DAAW); Lot No. 62676174 (Serial Numbers: 4014DABA, 4014DABB, 4014DABC, 4014DABD, 4014DABE, 4014DABF, 4014DABG, 4014DABH, 4014DABJ, 4014DABK, 4014DABL, 4014DABM, 4014DABN, 4014DABP, 4014DABQ, 4014DABR, 4014DABS, 4014DABT, 4014DABU, 4014DABW); Lot No. 62686165 (Serial Numbers: 4014DACA, 4014DACB, 4014DACC, 4014DACD, 4014DACE, 4014DACF, 4014DACG, 4014DACH, 4014DACJ, 4014DACK, 4014DACL, 4014DACM, 4014DACN, 4014DACP, 4014DACQ, 4014DACR, 4014DACS, 4014DACT, 4014DACU, 4014DACW); Lot No. 62686166 (Serial No. 4014DADA, 4014DADB, 4014DADC, 4014DADD, 4014DADE, 4014DADF, 4014DADG, 4014DADH, 4014DADJ, 4014DADK, 4014DADL, 4014DADM, 4014DADN, 4014DADP, 4014DADQ, 4014DADR, 4014DADS, 4014DADT, 4014DADU, 4014DADW); Lot No. 62686167 (Serial Numbers: 4014DAEA, 4014DAEB, 4014DAEC, 4014DAED, 4014DAEE, 4014DAEF, 4014DAEG, 4014DAEH, 4014DAEJ, 4014DAEK, 4014DAEL, 4014DAEM, 4014DAEN, 4014DAEP, 4014DAEQ, 4014DAER, 4014DAES, 4014DAET, 4014DAEU, 4014DAEW); Lot No. 62689574 (Serial Numbers: 4014DAFA, 4014DAFB, 4014DAFC, 4014DAFD, 4014DAFE, 4014DAFF, 4014DAFG, 4014DAFH, 4014DAFJ, 4014DAFK, 4014DAFL, 4014DAFM, 4014DAFN, 4014DAFP, 4014DAFQ, 4014DAFR, 4014DAFS, 4014DAFT, 4014DAFU, 4014DAFW); Lot No. 62689575 (Serial Numbers: 4014DAGA, 4014DAGB, 4014DAGC, 4014DAGD, 4014DAGE, 4014DAGF, 4014DAGG, 4014DAGH, 4014DAGJ, 4014DAGK, 4014DAGL, 4014DAGM, 4014DAGN, 4014DAGP, 4014DAGQ, 4014DAGR, 4014DAGS, 4014DAGT, 4014DAGU, 4014DAGW); Lot No. 62689611 (Serial Numbers: 4014EAAA, 4014EAAB, 4014EAAC, 4014EAAD, 4014EAAE, 4014EAAF, 4014EAAG, 4014EAAH, 4014EAAJ, 4014EAAK, 4014EAAL, 4014EAAM, 4014EAAN, 4014EAAP, 4014EAAQ, 4014EAAR, 4014EAAS, 4014EAAT, 4014EAAU, 4014EAAW); Lot No. 62689602 (Serial Numbers: 4014EABA, 4014EABB, 4014EABC, 4014EABD, 4014EABE, 4014EABF, 4014EABG, 4014EABH, 4014EABJ, 4014EABK, 4014EABL, 4014EABM, 4014EABN, 4014EABP, 4014EABQ, 4014EABR, 4014EABS, 4014EABT, 4014EABU, 4014EABW); Lot No. 62689620 (Serial Numbers: 4014EACA, 4014EACB, 4014EACC, 4014EACD, 4014EACE, 4014EACF, 4014EACG, 4014EACH, 4014EACJ, 4014EACK, 4014EACL, 4014EACM, 4014EACN, 4014EACP, 4014EACQ, 4014EACR, 4014EACS, 4014EACT, 4014EACU, 4014EACW); Lot No. 62689623 (Serial Numbers: 4014EADA, 4014EADB, 4014EADC, 4014EADD, 4014EADE, 4014EADF, 4014EADG, 4014EADH, 4014EADJ, 4014EADK, 4014EADL, 4014EADM, 4014EADN, 4014EADP, 4014EADQ, 4014EADR, 4014EADS, 4014EADT, 4014EADU, 4014EADW); Lot No. 62675189 (Serial Number: 4014DAHA); Lot No. 62688979 (Serial Numbers: 4014DAHB, 4014DAHC, 4014DAHD, 4014DAHE, 4014DAHF, 4014DAHG); Lot No. 62673235 (Serial Number: 4014DAHH); Lot No. 62683264 (Serial Number: 4014DAHJ); Lot No. 62726132 (Serial Numbers: 4014FAAA, 4014FAAB, 4014FAAC, 4014FAAD, 4014FAAE, 4014FAAF, 4014FAAG, 4014FAAH, 4014FAAJ, 4014FAAK, 4014FAAL, 4014FAAM, 4014FAAN, 4014FAAP, 4014FAAQ); Lot No. 62726133 (Serial Numbers: 4014FAAR); Lot No. 62732712 (Serial Numbers: 4014FAAS, 4014FAAT, 4014FAAU, 4014FAAW); Lot No. 62732713 (Serial Numbers: 4014FABA, 4014FABB); Lot No. 62727350 (Serial Numbers: 4014FABC, 4014FABD, 4014FABE, 4014FABF); Lot No. 62728452 (Serial Numbers: 4014FABG, 4014FABH); Lot No. 62723751 (Serial Numbers: 4014FABJ, 4014FABK, 4014FABL, 4014FABM, 4014FABN, 4014FABP, 4014FABQ, 4014FABR, 4014FABS, 4014FABT, 4014FABU, 4014FABW, 4014FACA, 4014FACB, 4014FACC, 4014FACD, 4014FACE, 4014FACF, 4014FACG, 4014FACH, 4014FACJ, 4014FACK, 4014FACL, 4014FACM, 4014FACN, 4014FACP, 4014FACQ, 4014FACR, 4014FACS, 4014FACT, 4014FACU, 4014FACW, 4014FADA, 4014FADB, 4014FADC, 4014FADD, 4014FADE, 4014FADF, 4014FADG, 4014FADH); Lot No. 62723752 (Serial Numbers: 4014FADJ, 4014FADK, 4014FADL, 4014FADM, 4014FADN, 4014FADP, 4014FADQ, 4014FADR, 4014FADS, 4014FADT, 4014FADU, 4014FADW, 4014FAEA, 4014FAEB, 4014FAEC, 4014FAED, 4014FAEE, 4014FAEF, 4014FAEG, 4014FAEH); Lot No. 62745917 (Serial Numbers: 4014FAEJ, 4014FAEK); Lot No. 62745898 (Serial Numbers: 4014FAEL, 4014FAEM, 4014FAEN); Lot No. 62749571 (Serial Numbers: 4014FAEP, 4014FAEQ, 4014FAER, 4014FAES, 4014FAET); Lot No. 62741841 (Serial Numbers: 4014FAEU, 4014FAEW, 4014FAFA, 4014FAFB, 4014FAFC, 4014FAFD, 4014FAFE, 4014FAFF, 4014FAFG, 4014FAFH, 4014FAFJ, 4014FAFK, 4014FAFL, 4014FAFM, 4014FAFN, 4014FAFP, 4014FAFQ, 4014FAFR, 4014FAFS, 4014FAFT); Lot No. 62723753 (Serial Numbers: 4014FAFU, 4014FAFW, 4014FAGA, 4014FAGB, 4014FAGC, 4014FAGD, 4014FAGE, 4014FAGF, 4014FAGG, 4014FAGH, 4014FAGJ, 4014FAGK, 4014FAGL, 4014FAGM, 4014FAGN, 4014FAGP, 4014FAGQ, 4014FAGR, 4014FAGS, 4014FAGT); Lot No. 62723754 (Serial Numbers: 4014FAJW, 4014FAKA, 4014FAKB, 4014FAKC, 4014FAKD, 4014FAKE, 4014FAKF, 4014FAKG, 4014FAKH, 4014FAKJ, 4014FAKK, 4014FAKL, 4014FAKM, 4014FAKN, 4014FAKP, 4014FAKQ, 4014FAKR, 4014FAKS, 4014FAKT, 4014FAKU); Lot No. 62745156 (Serial Numbers: 4014FAGU, 4014FAGW, 4014FAHA, 4014FAHB, 4014FAHC, 4014FAHD, 4014FAHE, 4014FAHF, 4014FAHG, 4014FAHH, 4014FAHJ, 4014FAHK, 4014FAHL, 4014FAHM, 4014FAHN, 4014FAHP, 4014FAHQ, 4014FAHR, 4014FAHS, 4014FAHT); Lot No. 62745158 (Serial Numbers: 4014FAKW, 4014FALA, 4014FALB, 4014FALC, 4014FALD, 4014FALE, 4014FALF, 4014FALG, 4014FALH, 4014FALJ, 4014FALK, 4014FALL, 4014FALM, 4014FALN, 4014FALP, 4014FALQ, 4014FALR, 4014FALS, 4014FALT, 4014FALU); Lot No. 62760910 (Serial Numbers: 4014GAAA, 4014GAAB, 4014GAAC, 4014GAAD, 4014GAAE, 4014GAAF); Lot No. 62769952 (Serial Numbers: 4014GAAG, 4014GAAH); Lot No. 62769958 (Serial Numbers: 4014GAAJ, 4014GAAK); Lot No. 62775967 (Serial Numbers: 4014GAAL, 4014GAAM, 4014GAAN, 4014GAAP); Lot No. 62748382 (Serial Numbers: 4014GAAQ, 4014GAAR, 4014GAAS, 4014GAAT, 4014GAAU, 4014GAAW, 4014GABA, 4014GABB, 4014GABC, 4014GABD, 4014GABE, 4014GABF, 4014GABG, 4014GABH, 4014GABJ, 4014GABK, 4014GABL, 4014GABM, 4014GABN, 4014GABP); Lot No. 62748393 (Serial Numbers: 4014GABQ, 4014GABR, 4014GABS, 4014GABT, 4014GABU, 4014GABW, 4014GACA, 4014GACB, 4014GACC, 4014GACD, 4014GACE, 4014GACF, 4014GACG,4014GACH, 4014GACJ, 4014GACK, 4014GACL, 4014GACM, 4014GACN, 4014GACP); Lot No. 62778431 (Serial Numbers: 4014GACQ, 4014GACR, 4014GACS, 4014GACT, 4014GACU, 4014GACW); Lot No. 62748405 (Serial Numbers: 4014GADA, 4014GADB, 4014GADC, 4014GADD, 4014GADE, 4014GADF, 4014GADG, 4014GADH, 4014GADJ, 4014GADK, 4014GADL, 4014GADM, 4014GADN, 4014GADP, 4014GADQ, 4014GADR, 4014GADS, 4014GADT, 4014GADU, 4014GADW); Lot No. 62779666 (Serial Numbers: 4014GAEA, 4014GAEB, 4014GAEC, 4014GAED); Lot No. 62779665 (Serial Numbers: 4014GAEE, 4014GAEF, 4014GAEG, 4014GAEH, 4014GAEJ); Lot No. 62748415 (Serial Numbers: 4014GAEK, 4014GAEL, 4014GAEM, 4014GAEN, 4014GAEP, 4014GAEQ, 4014GAER, 4014GAES, 4014GAET, 4014GAEU, 4014GAEW, 4014GAFA, 4014GAFB, 4014GAFC, 4014GAFD, 4014GAFE, 4014GAFF, 4014GAFG, 4014GAFH, 4014GAFJ); Lot No. 62797834 (Serial Numbers: 4014HAAA, 4014HAAB, 4014HAAC, 4014HAAD, 4014HAAE); Lot No. 62786181 (Serial Numbers: 4014HAAF, 4014HAAG, 4014HAAH, 4014HAAJ, 4014HAAK, 4014HAAL, 4014HAAM, 4014HAAN, 4014HAAP, 4014HAAQ, 4014HAAR, 4014HAAS, 4014HAAT, 4010HAAU, 4014HAAW, 4014HABA, 4014HABB, 4014HABC, 4014HABD, 4014HABE); Lot No. 62786182 (Serial Numbers: 4014HABF, 4014HABG, 4014HABH, 4014HABJ, 4014HABK, 4014HABL, 4014HABM, 4014HABN, 4014HABP, 4014HABQ, 4014HABR, 4014HABS, 4014HABT, 4014HABU, 4014HABW, 4014HACA, 4014HACB, 4014HACC, 4014HACD, 4014HACE); Lot No. 62791623 (Serial Numbers: 4014HACF, 4014HACG, 4014HACH, 4014HACJ, 4014HACK, 4014HACL, 4014HACM, 4014HACN, 4014HACP, 4014HACQ, 4014HACR, 4014HACS, 4014HACT, 4014HACU, 4014HACW, 4014HADA, 4014HADB, 4014HADC, 4014HADD, 4014HADE); Lot No. 62809993 (Serial Numbers: 4014HADF, 4014HADG, 4014HADH, 4014HADJ, 4014HADK, 4014HADL, 4014HADM, 4014HADN, 4014HADP, 4014HADQ, 4014HADR, 4014HADS, 4014HADT, 4014HADU, 4014HADW, 4014HAEA, 4014HAEB, 4014HAEC, 4014HAED, 4014HAEE); Lot No. 62812519 (Serial Numbers: 4014IAAA, 4014IAAB, 4014IAAC, 4014IAAD, 4014IAAE, 4014IAAF, 4014IAAG, 4014IAAH, 4014IAAJ, 4014IAAK, 4014IAAL, 4014IAAM, 4014IAAN, 4014IAAP, 4014IAAQ, 4014IAAR, 4014IAAS, 4014IAAT, 4014IAAU, 4014IAAW); Lot No. 62812815 (Serial Numbers: 4014IABA, 4014IABB, 4014IABC, 4014IABD, 4014IABE, 4014IABF, 4014IABG, 4014IABH, 4014IABJ, 4014IABK, 4014IABL, 4014IABM, 4014IABN, 4014IABP, 4014IABQ, 4014IABR, 4014IABS, 4014IABT, 4014IABU, 4014IABW); Lot No. 62824837 (Serial Numbers: 4014IACA, 4014IACB, 4014IACC, 4014IACD); Lot No. 62826497 (Serial Numbers: 4014IACE); Lot No. 62812816 (Serial Numbers: 4014IACF, 4014IACG, 4014IACH, 4014IACJ, 4014IACK, 4014IACL, 4014IACM, 4014IACN, 4014IACP, 4014IACQ, 4014IACR, 4014IACS, 4014IACT, 4014IACU, 4014IACW, 4014IADA, 4014IADB, 4014IADC, 4014IADD, 4014IADE); Lot No. 62831377 (Serial Numbers: 4014IADF); Lot No. 62812843 (Serial Numbers: 4014IADG, 4014IADH, 4014IADJ, 4014IADK, 4014IADL, 4014IADM, 4014IADN, 4014IADP, 4014IADQ, 4014IADR, 4014IADS, 4014IADT, 4014IADU, 4014IADW, 4014IAEA, 4014IAEB, 4014IAEC, 4014IAED, 4014IAEE, 4014IAEF); Lot No. 62838045 (Serial Numbers: 4014IAEG, 4014IAEH, 4014IAEJ, 4014IAEK, 4014IAEL, 4014IAEM, 4014IAEN); Lot No. 62812844 (Serial Numbers: 4014IAEP, 4014IAEQ, 4014IAER, 4014IAES, 4014IAET, 4014IAEU, 4014IAEW, 4014IAFA, 4014IAFB, 4014IAFC, 4014IAFD, 4014IAFE, 4014IAFF, 4014IAFG, 4014IAFH, 4014IAFJ, 4014IAFK, 4014IAFL, 4014IAFM, 4014IAFN); Lot No. 62812857 (Serial Numbers: 4014IAFP, 4014IAFQ, 4014IAFR, 4014IAFS, 4014IAFT, 4014IAFU, 4014IAFW, 4014IAGA, 4014IAGB, 4014IAGC, 4014IAGD, 4014IAGE, 4014IAGF, 4014IAGG, 4014IAGH, 4014IAGJ, 4014IAGK, 4014IAGL, 4014IAGM, 4014IAGN); Lot No. 62832912 (Serial Numbers: 4014JAAA, 4014JAAB, 4014JAAC, 4014JAAD, 4014JAAE, 4014JAAF, 4014JAAG, 4014JAAH, 4014JAAJ, 4014JAAK, 4014JAAL, 4014JAAM, 4014JAAN, 4014JAAP, 4014JAAQ, 4014JAAR, 4014JAAS, 4014JAAT 4014JAAU, 4014JAAW); Lot No. 62845553 (Serial Numbers: 4014JABA, 4014JABB, 4014JABC, 4014JABD, 4014JABE, 4014JABF, 4014JABG, 4014JABH, 4014JABJ, 4014JABK, 4014JABL, 4014JABM, 4014JABN, 4014JABP, 4014JABQ, 4014JABR, 4014JABS, 4014JABT, 4014JABU, 4014JABW); Lot No. 62832932 (Serial Numbers: 4014JACA, 4014JACB, 4014JACC, 4014JACD, 4014JACE, 4014JACF, 4014JACG, 4014JACH, 4014JACJ, 4014JACK, 4014JACL, 4014JACM, 4014JACN, 4014JACP, 4014JACQ, 4014JACR, 4014JACS, 4014JACT, 4014JACU, 4014JACW); Lot No. 62852357 (Serial Numbers: 4014JADA, 4014JADB, 4014JADC, 4014JADD, 4014JADE); Lot No. 62845554 (Serial Numbers: 4014JADF, 4014JADG, 4014JADH, 4014JADJ, 4014JADK, 4014JADL, 4014JADM, 4014JADN, 4014JADP, 4014JADQ, 4014JADR, 4014JADS, 4014JADT, 4014JADU, 4014JADW, 4014JAEA, 4014JAEB, 4014JAEC, 4014JAED, 4014JAEE); Lot No. 62832930 (Serial Numbers: 4014JAEF, 4014JAEG, 4014JAEH, 4014JAEJ, 4014JAEK, 4014JAEL, 4014JAEM, 4014JAEN, 4014JAEP, 4014JAEQ, 4014JAER, 4014JAES, 4014JAET, 4014JAEU, 4014JAEW, 4014JAFA, 4014JAFB, 4014JAFC, 4014JAFD, 4014JAFE); Lot No. 62835917 (Serial Numbers: 4014JAFF, 4014JAFG, 4014JAFH, 4014JAFJ, 4014JAFK, 4014JAFL, 4014JAFM, 4014JAFN, 4014JAFP, 4014JAFQ, 4014JAFR, 4014JAFS, 4014JAFT, 4014JAFU, 4014JAFW, 4014JAGA, 4014JAGB, 4014JAGC, 4014JAGD, 4014JAGE); Lot No. 62836063 (Serial Numbers: 4014JAGF, 4014JAGG, 4014JAGH, 4014JAGJ, 4014JAGK, 4014JAGL, 4014JAGM, 4014JAGN, 4014JAGP, 4014JAGQ, 4014JAGR, 4014JAGS, 4014JAGT, 4014JAGU, 4014JAGW, 4014JAHA, 4014JAHB, 4014JAHC, 4014JAHD, 4014JAHE); Lot No. 62836101 (Serial Numbers: 4014JAHF, 4014JAHG, 4014JAHH, 4014JAHJ, 4014JAHK, 4014JAHL, 4014JAHM, 4014JAHN, 4014JAHP, 4014JAHQ, 4014JAHR, 4014JAHS, 4014JAHT, 4014JAHU, 4014JAHW, 4014JAJA, 4014JAJB, 4014JAJC, 4014JAJD, 4014JAJE); Lot No. 62860464 (Serial Numbers: 4014JAJF, 4014JAJG, 4014JAJH, 4014JAJJ, 4014JAJK, 4014JAJL, 4014JAJM, 4014JAJN, 4014JAJP, 4014JAJQ, 4014JAJR, 4014JAJS, 4014JAJT, 4014JAJU, 4014JAJW, 4014JAKA, 4014JAKB, 4014JAKC, 4014JAKD, 4014JAKE); Lot No. 62860465 (Serial Numbers: 4014JAKF, 4014JAKG, 4014JAKH, 4014JAKJ, 4014JAKK, 4014JAKL, 4014JAKM, 4014JAKN, 4014JAKP, 4014JAKQ, 4014JAKR, 4014JAKS, 4014JAKT, 4014JAKU, 4014JAKW, 4014JALA, 4014JALB, 4014JALC, 4014JALD, 4014JALE); Lot No. 62870930 (Serial Numbers: 4014KAAA, 4014KAAB, 4014KAAC, 4014KAAD, 4014KAAE, 4014KAAF, 4014KAAG, 4014KAAH, 4014KAAJ, 4014KAAK, 4014KAAL, 4014KAAM, 4014KAAN, 4014KAAP, 4014KAAQ, 4014KAAR, 4014KAAS, 4014KAAT, 4014KAAU, 4014KAAW); Lot No. 62870931 (Serial Numbers: 4014KABA, 4014KABB, 4014KABC, 4014KABD, 4014KABE, 4014KABF, 4014KABG, 4014KABH, 4014KABJ, 4014KABK, 4014KABL, 4014KABM, 4014KABN, 4014KABP, 4014KABQ, 4014KABR, 4014KABS, 4014KABT, 4014KABU, 4014KABW); Lot No. 62869995 (Serial Numbers: 4014KACA, 4014KACB, 4014KACC, 4014KACD, 4014KACE); Lot No. 62869994 (Serial Numbers: 4014KACF, 4014KACG, 4014KACH, 4014KACJ, 4014KACK) Lot No. 62876470 (Serial Numbers: 4014KACL, 4014KACM, 4014KACN, 4014KACP, 4014KACQ, 4014KACR, 4014KACS, 4014KACT, 4014KACU, 4014KACW, 4014KADA, 4014KADB,4014KADC, 4014KADD, 4014KADE ,4014KADF,4014KADG ,4014KADH,4014KADJ, 4014KADK); Lot No. 62876471 (Serial Numbers: 4014KADL, 4014KADM, 4014KADN, 4014KADP, 4014KADQ, 4014KADR, 4014KADS, 4014KADT, 4014KADU, 4014KADW, 4014KAEA, 4014KAEB, 4014KAEC, 4014KAED, 4014KAEE, 4014KAEF, 4014KAEG, 4014KAEH, 4014KAEJ, 4014KAEK); Lot No. 62877398 (Serial Numbers: 401411110001, 401411110002, 401411110003, 401411110004, 401411110005, 401411110006, 401411110007, 401411110008, 401411110009, 401411110010, 401411110011, 401411110012, 401411110013, 401411110014, 401411110015, 401411110016, 401411110017, 401411110018, 401411110019, 401411110020); Lot No. 62877405 (Serial Numbers: 401411110021, 401411110022, 401411110023, 401411110024, 401411110025, 401411110026, 401411110027, 401411110028, 401411110029, 401411110030, 401411110031, 401411110032, 401411110033, 401411110034, 401411110035, 401411110036, 401411110037, 401411110038, 401411110039, 401411110040); Lot No. 62885591 (Serial Numbers: 401411140001, 401411140002, 401411140003, 401411140004, 401411140005); Lot No. 62877414 (Serial Numbers: 401411140006, 401411140007, 401411140008, 401411140009, 401411140010, 401411140011, 401411140012, 401411140013, 401411140014, 401411140015, 401411140016, 401411140017, 401411140018, 401411140019, 401411140020, 401411140021, 401411140022, 401411140023, 401411140024, 401411140025); Lot No. 62885589 (Serial Numbers: 401411150001, 401411150002, 401411150003, 401411150004, 401411150005); Lot No. 62885588 (Serial Numbers: 401411170001, 401411170002, 401411170003, 401411170004, 401411170005); Lot No. 62877415 (Serial Numbers: 401411180001, 401411180002, 401411180003, 401411180004, 401411180005, 401411180006, 401411180007, 401411180008, 401411180009, 401411180010, 401411180011, 401411180012, 401411180013, 401411180014, 401411180015, 401411180016, 401411180017, 401411180018, 401411180019, 401411180020); Lot No. 62904095 (Serial Numbers: 401411200001, 401411200002, 401411200003, 401411200004, 401411200005, 401411200006, 401411200007, 401411200008, 401411200009, 401411200010, 401411200011, 401411200012, 401411200013, 401411200014, 401411200015, 401411200016, 401411200017, 401411200018, 401411200019, 401411200020); Lot No. 62904096 (Serial Numbers: 401411250001, 401411250002, 401411250003, 401411250004, 401411250005, 401411250006, 401411250007, 401411250008, 401411250009, 401411250010, 401411250011, 401411250012, 401411250013, 401411250014, 401411250015, 401411250016, 401411250017, 401411250018, 401411250019, 401411250020); Lot No. 62904127 (Serial Numbers: 401412020001, 401412020002, 401412020003, 401412020004, 401412020005, 401412020006, 401412020007, 401412020008, 401412020009, 401412020010, 401412020011, 401412020012, 401412020013, 401412020014, 401412020015, 401412020016, 401412020017, 401412020018, 401412020019, 401412020020); Lot No. 62878965 (Serial Numbers: 401412040001, 401412040002, 401412040003, 401412040004, 401412040005); Lot No. 62885590 (Serial Numbers: 401412050001, 401412050002, 401412050003, 401412050004, 401412050005, 401412050006, 401412050007, 401412050008, 401412050009, 401412050010); Lot No. 62894035 (Serial Numbers: 401412080001, 401412080002, 401412080003, 401412080004, 401412080005); Lot No. 62904131 (Serial Numbers: 401412090001, 401412090002, 401412090003, 401412090004, 401412090005, 401412090006, 401412090007, 401412090008, 401412090009, 401412090010, 401412090011, 401412090012, 401412090013, 401412090014, 401412090015, 401412090016, 401412090017, 401412090018, 401412090019, 401412090020); Lot No. 62905841 (Serial Numbers: 401412110001, 401412110002, 401412110003, 401412110004, 401412110005); Lot No. 62904271 (Serial Numbers: 401412120001, 401412120002, 401412120003, 401412120004, 401412120005, 401412120006, 401412120007, 401412120008, 401412120009, 401412120010, 401412120011, 401412120012, 401412120013, 401412120014, 401412120015, 401412120016, 401412120017, 401412120018, 401412120019, 401412120020); Lot No. 62905845 (Serial Numbers: 401412120021, 401412120022, 401412120023, 401412120024, 401412120025); Lot No. 62932765 (Serial Numbers: 401412160001, 401412160002, 401412160003, 401412160004, 401412160005); Lot No. 62904272 (Serial Numbers: 401412170001, 401412170002, 401412170003, 401412170004, 401412170005, 401412170006, 401412170007, 401412170008, 401412170009, 401412170010, 401412170011, 401412170012, 401412170013, 401412170014, 401412170015, 401412170016, 401412170017, 401412170018, 401412170019, 401412170020); Lot No. 62932247 (Serial Numbers: 401501020001, 401501020002, 401501020003, 401501020004, 401501020005, 401501020006, 401501020007, 401501020008, 401501020009, 401501020010, 401501020011, 401501020012, 401501020013, 401501020014, 401501020015, 401501020016, 401501020017, 401501020018, 401501020019, 401501020020); Lot No. 62932251 (Serial Numbers: 401501080001, 401501080002, 401501080003, 401501080004, 401501080005, 401501080006, 401501080007, 401501080008, 401501080009, 401501080010, 401501080011, 401501080012, 401501080013, 401501080014, 401501080015, 401501080016, 401501080017, 401501080018, 401501080019, 401501080020); Lot No. 62932249 (Serial Numbers: 401501080021, 401501080022, 401501080023, 401501080024, 401501080025, 401501080026, 401501080027, 401501080028, 401501080029, 401501080030, 401501080031, 401501080032, 401501080033, 401501080034, 401501080035, 401501080036, 401501080037, 401501080038, 401501080039, 401501080040); Lot No. 62932628 (Serial Numbers: 401501090001, 401501090002, 401501090003, 401501090004, 401501090005, 401501090006, 401501090007, 401501090008, 401501090009, 401501090010, 401501090011, 401501090012, 401501090013, 401501090014, 401501090015, 401501090016, 401501090017, 401501090018, 401501090019, 401501090020); Lot No. 62945084 (Serial Numbers: 401501090021, 401501090022, 401501090023, 401501090024, 401501090025); Lot No. 62932630 (Serial Numbers: 401501120001, 401501120002, 401501120003, 401501120004, 401501120005, 401501120006, 401501120007, 401501120008, 401501120009, 401501120010, 401501120011, 401501120012, 401501120013, 401501120014, 401501120015, 401501120016, 401501120017, 401501120018, 401501120019, 401501120020); Lot No. 62932632 (Serial Numbers: 401501130001, 401501130002, 401501130003, 401501130004, 401501130005, 401501130006, 401501130007, 401501130008, 401501130009, 401501130010, 401501130011, 401501130012, 401501130013, 401501130014, 401501130015, 401501130016, 401501130017, 401501130018, 401501130019, 401501130020); Lot No. 62932651 (Serial Numbers: 401501140001, 401501140002, 401501140003, 401501140004, 401501140005, 401501140006, 401501140007, 401501140008, 401501140009, 401501140010, 401501140011, 401501140012, 401501140013, 401501140014, 401501140015, 401501140016, 401501140017, 401501140018, 401501140019, 401501140020); Lot No. 62932652 (Serial Numbers: 401501150001, 401501150002, 401501150003, 401501150004, 401501150005, 401501150006, 401501150007, 401501150008, 401501150009, 401501150010, 401501150011, 401501150012, 401501150013, 401501150014, 401501150015, 401501150016, 401501150017, 401501150018, 401501150019, 401501150020); Lot No. 62932663 (Serial Numbers: 401501200001, 401501200002, 401501200003, 401501200004, 401501200005, 401501200006, 401501200007, 401501200008, 401501200009, 401501200010, 401501200011, 401501200012, 401501200013, 401501200014, 401501200015, 401501200016, 401501200017, 401501200018, 401501200019, 401501200020); Lot No. 62932666 (Serial Numbers: 401501210001, 401501210002, 401501210003, 401501210004, 401501210005, 401501210006, 401501210007, 401501210008, 401501210009, 401501210010, 401501210011, 401501210012, 401501210013, 401501210014, 401501210015, 401501210016, 401501210017, 401501210018, 401501210019, 401501210020); Lot No. 62962026 (Serial Numbers: 401501230001, 401501230002, 401501230003); Lot No. 62961808 (Serial Numbers: 401501260001, 401501260002, 401501260003, 401501260004, 401501260005, 401501260006, 401501260007, 401501260008, 401501260009, 401501260010, 401501260011, 401501260012, 401501260013, 401501260014, 401501260015, 401501260016, 401501260017, ,401501260018, 401501260019, 401501260020); Lot No. 62961810 (Serial Numbers: 401501290001, 401501290002, 401501290003, 401501290004, 401501290005, 401501290006, 401501290007, 401501290008, 401501290009, 401501290010, 401501290011, 401501290012, 401501290013, 401501290014, 401501290015, 401501290016, 401501290017, 401501290018, 401501290019, 401501290020); Lot No. 62945079 (Serial Numbers: 401502050001, 401502050002, 401502050003, 401502050004, 401502050005, 401502050006, 401502050007, 401502050008, 401502050009, 401502050010); Lot No. 62961812 (Serial Numbers: 401502060001, 401502060002, 401502060003, 401502060004, 401502060005, 401502060006, 401502060007, 401502060008, 401502060009, 401502060010, 401502060011, 401502060012, 401502060013, 401502060014, 401502060015, 401502060016, 401502060017, 401502060018, 401502060019, 401502060020); Lot No. 62969001 (Serial Numbers: 401502070001, 401502070002, 401502070003, 401502070004, 401502070005); Lot No. 62961815 (Serial Numbers: 401502120001, 401502120002, 401502120003, 401502120004, 401502120005, 401502120006, 401502120007, 401502120008, 401502120009, 401502120010, 401502120011, 401502120012, 401502120013, 401502120014, 401502120015, 401502120016, 401502120017, 401502120018, 401502120019, 401502120020); Lot No. 62961816 (Serial Numbers: 401502170001, 401502170002, 401502170003, 401502170004, 401502170005, 401502170006, 401502170007, 401502170008, 401502170009, 401502170010, 401502170011, 401502170012, 401502170013, 401502170014, 401502170015, 401502170016, 401502170017, 401502170018, 401502170019, 401502170020); Lot No. 62985038 (Serial Numbers: 401502180001, 401502180002, 401502180003, 401502180004, 401502180005, 401502180006, 401502180007, 401502180008, 401502180009, 401502180010); Lot No. 62961817 (Serial Numbers: 401502190001, 401502190002, 401502190003, 401502190004, 401502190005, 401502190006, 401502190007, 401502190008, 401502190009, 401502190010, 401502190011, 401502190012, 401502190013, 401502190014, 401502190015, 401502190016, 401502190017, 401502190018, 401502190019, 401502190020); Lot No. 62983026 (Serial Numbers: 401502190021, 401502190022, 401502190023, 401502190024, 401502190025); Lot No. 62961818 (Serial Numbers: 401502240001, 401502240002, 401502240003, 401502240004, 401502240005, 401502240006, 401502240007, 401502240008, 401502240009, 401502240010, 401502240011, 401502240012, 401502240013, 401502240014, 401502240015, 401502240016, 401502240017, 401502240018, 401502240019, 401502240020); Lot No. 62976482 (Serial Numbers: 401502260001, 401502260002, 401502260003, 401502260004, 401502260005, 401502260006, 401502260007, 401502260008, 401502260009, 401502260010, 401502260011, 401502260012, 401502260013, 401502260014, 401502260015, 401502260016, 401502260017, 401502260018, 401502260019, 401502260020); Lot No. 63000878 (Serial Numbers: 401503130001, 401503130002, 401503130003); Lot No. 63003147 (Serial Numbers: 401503190001, 401503190002, 401503190003, 401503190004, 401503190005); Lot No. 63003149 (Serial Numbers: 401503230001, 401503230002, 401503230003, 401503230004, 401503230005, 401503230006, 401503230007, 401503230008); Lot No. 62976483 (Serial Numbers: 401503310001, 401503310002, 401503310003, 401503310004, 401503310005, 401503310006, 401503310007, 401503310008, 401503310009, 401503310010, 401503310011, 401503310012, 401503310013, 401503310014, 401503310015, 401503310016, 401503310017, 401503310018, 401503310019, 401503310020); Lot No. 63007860 (Serial Numbers: 401504020001, 401504020002, 401504020003, 401504020004, 401504020005, 401504020006, 401504020007, 401504020008, 401504020009, 401504020010, 401504020011, 401504020012, 401504020013, 401504020014, 401504020015, 401504020016, 401504020017, 401504020018, 401504020019, 401504020020); Lot No. 63035646 (Serial Numbers: 401504060001, 401504060002, 401504060003, 401504060004, 401504060005, 401504060006, 401504060007, 401504060008); Lot No. 63035645 (Serial Numbers: 401504060009, 401504060010, 401504060011, 401504060012, 401504060013, 401504060014, 401504060015, 401504060016, 401504060017, 401504060018, 401504060019, 401504060020, 401504060021, 401504060022, 401504060023); Lot No. 63035647 (Serial Numbers: 401504090001, 401504090002, 401504090003, 401504090004, 401504090005, 401504090006, 401504090007, 401504090008, 401504090009, 401504090010); Lot No. 62976488 (Serial Numbers: 401504090011, 401504090012, 401504090013, 401504090014, 401504090015, 401504090016, 401504090017, 401504090018, 401504090019, 401504090020, 401504090021, 401504090022, 401504090023, 401504090024, 401504090025, 401504090026, 401504090027, 401504090028, 401504090029, 401504090030); Lot No. 63007861 (Serial Numbers: 401504150001, 401504150002, 401504150003, 401504150004, 401504150005, 401504150006, 401504150007, 401504150008, 401504150009, 401504150010, 401504150011, 401504150012, 401504150013, 401504150014, 401504150015, 401504150016, 401504150017, 401504150018, 401504150019, 401504150020); Lot No. 63007859 (Serial Numbers: 401504150021, 401504150022, 401504150023, 401504150024, 401504150025, 401504150026, 401504150027, 401504150028, 401504150029, 401504150030, 401504150031, 401504150032, 401504150033, 401504150034, 401504150035, 401504150036, 401504150037, 401504150038, 401504150039, 401504150040); Lot No. 63042185 (Serial Numbers: 401504200001, 401504200002, 401504200003, 401504200004, 401504200005); Lot No. 63007862 (Serial Numbers: 401504210001, 401504210002, 401504210003, 401504210004, 401504210005, 401504210006, 401504210007, 401504210008, 401504210009, 401504210010, 401504210011, 401504210012, 401504210013, 401504210014, 401504210015, 401504210016, 401504210017, 401504210018, 401504210019, 401504210020); Lot No. 63042186 (Serial Numbers: 401504210021, 401504210022, 401504210023, 401504210024, 401504210025, 401504210026, 401504210027, 401504210028, 401504210029, 401504210030, 401504210031, 401504210032, 401504210033, 401504210034, 401504210035, 401504210036, 401504210037, 401504210038, 401504210039, 401504210040); Lot No. 63007864 (Serial Numbers: 401504240001, 401504240002, 401504240003, 401504240004, 401504240005, 401504240006, 401504240007, 401504240008, 401504240009, 401504240010, 401504240011, 401504240012, 401504240013, 401504240014, 401504240015, 401504240016, 401504240017, 401504240018, 401504240019, 401504240020); Lot No. 63037265 (Serial Numbers: 401504270001, 401504270002, 401504270003, 401504270004, 401504270005, 401504270006, 401504270007, 401504270008, 401504270009, 401504270010, 401504270011, 401504270012, 401504270013, 401504270014, 401504270015, 401504270016, 401504270017, 401504270018, 401504270019, 401504270020); Lot No. 63037270 (Serial Numbers: 401504290001, 401504290002, 401504290003, 401504290004, 401504290005, 401504290006, 401504290007, 401504290008, 401504290009, 401504290010, 401504290011, 401504290012, 401504290013, 401504290014, 401504290015, 401504290016, 401504290017, 401504290018, 401504290019, 401504290020); Lot No. 63037272 (Serial Numbers: 401505010001, 401505010002, 401505010003, 401505010004, 401505010005, 401505010006, 401505010007, 401505010008, 401505010009, 401505010010, 401505010011, 401505010012, 401505010013, 401505010014, 401505010015, 401505010016, 401505010017, 401505010018, 401505010019, 401505010020); Lot No. 63037274 (Serial Numbers: 401505070001, 401505070002, 401505070003, 401505070004, 401505070005, 401505070006,
Other Recalls from Zimmer Surgical Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1202-2026 | Class II | Brand Name: Zimmer Tourniquet Systems Product ... | Dec 24, 2025 |
| Z-1201-2026 | Class II | Brand Name: Zimmer Tourniquet Systems Product ... | Dec 24, 2025 |
| Z-0924-2026 | Class II | Zimmer Air Dermatome, Model/Catalog Number: 008... | Nov 24, 2025 |
| Z-0925-2026 | Class II | Zimmer Dermatome AN, Model/Catalog Number: 8871... | Nov 24, 2025 |
| Z-1078-2024 | Class II | 3:1 Dermacarrier, Model Number 00219501300, ski... | Jan 2, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.