Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model number...
FDA Device Recall #Z-0580-2026 - Class II, September 16, 2025
Recall Summary
| Recall Number | Z-0580-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | September 16, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Sofamor Danek USA Inc |
| Location | Memphis, TN |
| Product Type | Devices |
| Quantity | 275,260 units |
Product Description
Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073. 2. SPACER 6068076 CATALYFT PL LONG 7MM, Model Number: 6068076. 3. SPACER 6068093 CATALYFT PL SHORT 9MM, Model Number: 6068093. 4. SPACER 6068096 CATALYFT PL LONG 9MM, Model Number: 6068096. 5. SPACER 6068113 CATALYFT PL SHORT 11MM, Model Number: 6068113. 6. SPACER 6068116 CATALYFT PL LONG 11MM, Model Number: 6068116. 7. SPACER 6069073 CATALYFT PL40 SHORT 7MM, Model Number: 6069073. 8. SPACER 6069076 CATALYFT PL40 LONG 7MM, Model Number: 6069076. 9. SPACER 6069093 CATALYFT PL40 SHORT 9MM, Model Number: 6069093. 10. SPACER 6069096 CATALYFT PL40 LONG 9MM, Model Number: 6069096. 11. SPACER 6069113 CATALYFT PL40 SHORT 11MM, Model Number: 6069113. 12. SPACER 6069116 CATALYFT PL40 LONG 11MM, Model Number: 6069116. 13. CATALYFT PL IMPLANT SET, Model Number: SPS03143. 14. CATALYFT PL 40 IMPLANT SET, Model Number: SPS03144. 15. KIT CATALYFT PL IMPLANTS, Model Number: SPS04012. 16. KIT CATALYFT PL 40 IMPLANTS, Model Number: SPS04013. 17. CATALYFT PL 40 IMP KIT, Model Number: SPSJEP40. 18. CATALYFT PL 40 HIGH IMP KIT, Model Number: SPSJEP4H. 19. CATALYFT PL 40 SHORT IMP KIT, Model Number: SPSJEP4S. 20. CATALYFT PL 40 SHORT HIGH IMP KIT, Model Number: SPSJEP4T. 21. CATALYFT PL STRAIGHT HIGH IMP KIT, Model Number: SPSJEPSH. 22. CATALYFT PL STRAIGHT IMP KIT, Model Number: SPSJEPSI. These systems utilize the following affected Instructions for Use (IFU), Document M333023W048E, and Surgical Technique Guide, Document M333023W217.
Reason for Recall
Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.
Distribution Pattern
Worldwide distribution - US Nationwide and Puerto Rico. The countries of Australia, Austria, Belgium, Canada, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Netherlands, New Caledonia, New Zealand, Norway, Portugal, Reunion, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
Lot / Code Information
IFU: M333023W048E Rev. A Surgical TechniqueM333023W217, Rev. 2.0 1. Model Number: 6068073. GTIN (Lot Numbers): 00763000246693 (0835083W, 0836192W, 0837725W, 0837727W, 0839577W, 0839579W, 0839591W, 0839593W, 0839595W, 0841459W, 0842257W, 0842767W, 0842769W, 0845001W, 0845003W, 0846533W, 0849546W, 0849548W, 0849998W, 0854451W, 0856696W, 0856698W, 0858703W, 0868179W, 0868231W, 0869637W, 0869695W, 0872240W, 0873202W, 0874502W, 0874504W, 0877435W, 0878670W, 0879342W, 0879887W, 0881316W, 0885958W, 0885960W, 0886068W, 0886070W, 0887342W, 0888799W, 0889934W, 0889936W, 0891419W, 0891951W, 0893270W, 0893332W, 0894905W, 0896952W, 0896954W, 0897308W, 0900773W, 0900970W, 0901192W, 0902362W, 0903362W, 0904350W, 0906154W, 0907656W, 0908818W, 0908820W, 0910150W, 0910202W, 0914572W, 0914574W, 0914576W, 0914578W, 0914580W, 0917478W, 0917480W, 0917662W, 0918071W, 0918073W, 0918075W, 0918077W, 0918858W, 0918860W, 0918862W, 0918864W, 0918866W, 0918886W, 0918888W, 0922033W, 0924471W, 0925397W, 0926139W, 0926361W, 0927266W, 0931914W, 0931916W, 0933069W, 0933071W, 0933073W, 0933075W, 0934823W, 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1057484W, 1057486W, 1057994W, 1057996W, 1057998W, 1058000W, 1058102W, 1058104W, 1058106W, 1058108W, 1059122W, 1059124W, 1059126W, 1059128W, 1059673W, 1059675W, 1059677W, 1059679W, 1059681W, 1059685W, 1060016W, 1060018W, 1060042W, 1061130W, 1061132W, 1061134W, 1061136W, 1061138W, 1061140W, 1062398W, 1062400W, 1062402W, 1062404W, 1062406W, 1062410W, 1062412W, 1062414W, 1062418W, 1063591W, 1063593W, 1063595W, 1063597W, 1063599W, 1063601W, 1063603W, 1063605W, 1064184W, 1064186W, 1064188W, 1064190W, 1064192W, 1064194W, 1064196W, 1064198W, 1064688W, 1064690W, 1064935W, 1064937W, 1064939W, 1065454W, 1065456W, 1065458W, 1065460W, 1065472W, 1065474W, 1065476W, 1065882W, 1065884W, 1066272W, 1066274W, 1066469W, 1067027W, 1067029W, 1067031W, 1067033W, 1067035W, 1067037W, 1067039W, 1067721W, 1067723W, 1067725W, 1068010W, 1068312W, 1068314W, 1068316W, 1068318W, 1068320W, 1068322W, 1068324W, 1069172W, 1069174W, 1069176W, 1069178W, 1069679W, 1069683W, 1069685W, 1069687W, 1069689W, 1069691W, 1069693W, 1069697W, 1069699W, 1070304W, 1070308W, 1070310W, 1070405W, 1070407W, 1070409W, 1071241W, 1071243W, 1071245W, 1071247W, 1071249W, 1071251W, 1071253W, 1071255W, 1071257W, 1071259W, 1071476W, 1071478W, 1072574W, 1072580W, 1072582W, H5949771, H5958086, H5960046, H5960960, H5962266, H5962482, H5963060, H5966757, H5966776, H5967705, H5968960, H5969220, H5969817, H5975991, H5979175, H5979177, H5980995, H5981839, H5983795, H5984549, H5990897, H5991698, H5993288, H5995524, H5996143, H5996159, H5996493, H5996497, H5998670, H6000399, H6004407, H6009899, H6010724, H6010732, H6013796, H6014111, H6014312, H6014313, H6014549, H6014720, H6015908, H6018002, H6018003, H6018630, H6018659, H6018660, H6018663, H6018664, H6018668, H6020623, H6023750, H6023890, H6024117, H6024652, H6030042, H6032572, H6032577, H6040357, H6041546, H6048295, H6048303, H6060354, H6060358, H6060602, H6060606, H6062043); 00763000529567 (0856698W, 0858703W, 0868179W, 0868231W, 0869637W, 0869695W, 0872240W, 0885958W, 0886068W, 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1050572W, 1050574W, 1050576W, 1050578W, 1050580W, 1050584W, 1050586W, 1050590W, 1050592W, 1052420W, 1056849W, 1057484W, 1057486W, 1059122W, 1059124W, 1059126W, 1059128W, 1059673W, 1059679W, 1059681W, 1060018W, 1060042W, 1061132W, 1061136W, 1061138W, 1061140W, H5962482, H5969220, H5979175, H5979177, H5980995, H5981839, H5983795, H5991698, H5993288, H6018660, H6024652, H6030042, H6032572, H6040357, 1002451W, 1008576W, 1040457W, 1056901W, H6028216). 2. Model Number: 6068076. GTIN (Lot Numbers): 00763000246709 (0831754W, 0836194W, 0836196W, 0837729W, 0842801W, 0844113W, 0848626W, 0851984W, 0852133W, 0852135W, 0854453W, 0855324W, 0858930W, 0860486W, 0862453W, 0869639W, 0869697W, 0870551W, 0873204W, 0873206W, 0874508W, 0877437W, 0879344W, 0879346W, 0879889W, 0881318W, 0881320W, 0881322W, 0881324W, 0888801W, 0891953W, 0891955W, 0891957W, 0891959W, 0891961W, 0893334W, 0895572W, 0896956W, 0896958W, 0897310W, 0900775W, 0901194W, 0902364W, 0903364W, 0904722W, 0906156W, 0907658W, 0910204W, 0910206W, 0914582W, 0917664W, 0920057W, 0920059W, 0922963W, 0924473W, 0928840W, 0929162W, 0931918W, 0933077W, 0933079W, 0933081W, 0935292W, 0935294W, 0936460W, 0937874W, 0939328W, 0940207W, 0940209W, 0941916W, 0943259W, 0943491W, 0943959W, 0947406W, 0948522W, 0948524W, 0951518W, 0952754W, 0952756W, 0954066W, 0954068W, 0955354W, 0955356W, 0955504W, 0955506W, 0957553W, 0957555W, 0959042W, 0959044W, 0961522W, 0962116W, 0962118W, 0962120W, 0962772W, 0962774W, 0967197W, 0967199W, 0967201W, 0969067W, 0973085W, 0974331W, 0974333W, 0975730W, 0976604W, 0976606W, 0976608W, 0976610W, 0976742W, 0978655W, 0978657W, 0980758W, 0980760W, 0980762W, 0983624W, 0986390W, 0989391W, 0992001W, 0992003W, 0992005W, 0992007W, 0992009W, 0993274W, 0993628W, 0993630W, 0995670W, 1002345W, 1002455W, 1002457W, 1003070W, 1003602W, 1004292W, 1004294W, 1004648W, 1004650W, 1005202W, 1007162W, 1007164W, 1007166W, 1007168W, 1007170W, 1007172W, 1007174W, 1007573W, 1007575W, 1007577W, 1007579W, 1007581W, 1007583W, 1010252W, 1010254W, 1010256W, 1010258W, 1010260W, 1010262W, 1010264W, 1010729W, 1011392W, 1011394W, 1011396W, 1011904W, 1011906W, 1013087W, 1013089W, 1013091W, 1013093W, 1013095W, 1013097W, 1013099W, 1014066W, 1014068W, 1014070W, 1014072W, 1014074W, 1014856W, 1014858W, 1014860W, 1015566W, 1015568W, 1015570W, 1015572W, 1015574W, 1015576W, 1015578W, 1016360W, 1018664W, 1018666W, 1019189W, 1019441W, 1019443W, 1019445W, 1019447W, 1019449W, 1020208W, 1020210W, 1020212W, 1020214W, 1020216W, 1020218W, 1021427W, 1021429W, 1021471W, 1021473W, 1021475W, 1021769W, 1022752W, 1024223W, 1025162W, 1026251W, 1026829W, 1027614W, 1027616W, 1027618W, 1027620W, 1028551W, 1030261W, 1031319W, 1031331W, 1031333W, 1031496W, 1031498W, 1031500W, 1031682W, 1032064W, 1032066W, 1032068W, 1032581W, 1032583W, 1032585W, 1033164W, 1033166W, 1033168W, 1033170W, 1033172W, 1033934W, 1034572W, 1034574W, 1034576W, 1034578W, 1034582W, 1034584W, 1036020W, 1036532W, 1036534W, 1036536W, 1036538W, 1036794W, 1036796W, 1036798W, 1036802W, 1041975W, 1041977W, 1041979W, 1042971W, 1043680W, 1043682W, 1043684W, 1043686W, 1043688W, 1043690W, 1044354W, 1044356W, 1044627W, 1044629W, 1044643W, 1044645W, 1044721W, 1045201W, 1045203W, 1045205W, 1045700W, 1045712W, 1045714W, 1046308W, 1046310W, 1046312W, 1046996W, 1046998W, 1047000W, 1047396W, 1047398W, 1048890W, 1048892W, 1054738W, 1054740W, 1054770W, 1054872W, 1054874W, 1055567W, 1055569W, 1055571W, 1055853W, 1055855W, 1055857W, 1056542W, 1056544W, 1056546W, 1057084W, 1057490W, 1057492W, 1057494W, 1058110W, 1067041W, H5949120, H5949481, H5953772, H5954271, H5960967, H5964111, H5964372, H5964627, H5965830, H5966104, H5968010, H5975985, H5976387, H5976389, H5976812, H5977791, H5979732, H5981967, H5982401, H5985530, H5985535, H5989329, H5990892, H5992876, H5993340, H5993606, H5994388, H5994451, H5997294, H5997295, H5997889, H5998255, H5998673, H5999512, H6000387, H6003392, H6003398, H6003403, H6004897, H6013456, H6015371, H6016681, H6020970, H6021535, H6023748, H6024154, H6024158, H6029815, H6029816, H6030132, H6030421, H6030423, H6030424, H6037256, H6040680, H6041095, H6046753, H6049447, H6049456, H6051115, H6051381, H6051486, H6051489, H6051620, H6051638, H6052354, H6054532, H6055364, H6059264, H6059280, H6060375, H6060376, H6061509, H6061801, H6061802, H6065331, H6065333, H6065334, H6066170, H6066171, H6066189, H6067518, H6067852, H6069509, H6069514, H6069738); 00763000529574 (0869639W, 0870551W, 0873204W, 0873206W, 0874508W, 0877437W, 0879344W, 0881320W, 0891957W, 0896958W, 0897310W, 0928840W, 0929162W, 0933077W, 0933079W, 0933081W, 0935292W, 0943959W, 0948522W, 0948524W, 0954066W, 0954068W, 0955354W, 0955356W, 0955504W, 0955506W, 0957553W, 0957555W, 0959042W, 0959044W, 0961522W, 0962120W, 0962774W, 0975730W, 0978655W, 0980758W, 0980762W, 0986390W, 0989391W, 0992003W, 0992009W, 0993274W, 1002455W, 1003070W, 1003602W, 1005202W, 1007162W, 1007172W, 1007174W, 1007573W, 1007577W, 1010256W, 1010262W, 1011394W, 1011906W, 1031333W, 1031496W, 1031500W, 1032066W, 1032068W, 1034572W, 1034584W, 1036020W, 1036534W, 1036798W, 1043684W, 1043686W, 1044354W, 1044645W, 1045712W, 1045714W, 1057492W, H5964111, H5964627, H5997294, H5997295, H5997889, H5998255, H5999512, H6016681, 0874506W). 3. Model Number: 6068093. GTIN (Lot Numbers): 00763000246723 (0831756W, 0837731W, 0839597W, 0842803W, 0844115W, 0846535W, 0847976W, 0849550W, 0850000W, 0850415W, 0850417W, 0850842W, 0862455W, 0865723W, 0868233W, 0868235W, 0869699W, 0870553W, 0870555W, 0870557W, 0871618W, 0874997W, 0874999W, 0877439W, 0879348W, 0879891W, 0881326W, 0881328W, 0881330W, 0889938W, 0891963W, 0893336W, 0893338W, 0893340W, 0895574W, 0895576W, 0896960W, 0898382W, 0900777W, 0901196W, 0902366W, 0903366W, 0904724W, 0906158W, 0907660W, 0910208W, 0910210W, 0914584W, 0914586W, 0917666W, 0920061W, 0920063W, 0922035W, 0922037W, 0922965W, 0924475W, 0929164W, 0929166W, 0931920W, 0933083W, 0936462W, 0936464W, 0936466W, 0939330W, 0940211W, 0940213W, 0944351W, 0947408W, 0948526W, 0950152W, 0951520W, 0952758W, 0952760W, 0954070W, 0954072W, 0955358W, 0955360W, 0955508W, 0957557W, 0957559W, 0959046W, 0959048W, 0959435W, 0959437W, 0961524W, 0967355W, 0967357W, 0967359W, 0969069W, 0973087W, 0974335W, 0974337W, 0976744W, 0976746W, 0978659W, 0980764W, 0980766W, 0980768W, 0980770W, 0982545W, 0983626W, 0983628W, 0983630W, 0984024W, 0987665W, 0987667W, 0992011W, 0992013W, 0993276W, 0999910W, 1002347W, 1002459W, 1002461W, 1002463W, 1002465W, 1003604W, 1003606W, 1004296W, 1005204W, 1008582W, 1008586W, 1008588W, 1008590W, 1008592W, 1008594W, 1008596W, 1010266W, 1010268W, 1010270W, 1010272W, 1010274W, 1010276W, 1010280W, 1011061W, 1011063W, 1011065W, 1011067W, 1011069W, 1011071W, 1011073W, 1013101W, 1013103W, 1014862W, 1014864W, 1014866W, 1014868W, 1016362W, 1020519W, 1020521W, 1021477W, 1021479W, 1021481W, 1021483W, 1021771W, 1021773W, 1021775W, 1023318W, 1023320W, 1023322W, 1023324W, 1023326W, 1024225W, 1024227W, 1024229W, 1024231W, 1024233W, 1024235W, 1024237W, 1025164W, 1025166W, 1025168W, 1025170W, 1025172W, 1026831W, 1026833W, 1026835W, 1033174W, 1033176W, 1033936W, 1033938W, 1033940W, 1033942W, 1033946W, 1033948W, 1035163W, 1035165W, 1035167W, 1035169W, 1035171W, 1036646W, 1036648W, 1036650W, 1036762W, 1036764W, 1038735W, 1051171W, 1051173W, 1051175W, 1051408W, 1051410W, 1051528W, 1051732W, 1051734W, 1051738W, 1052444W, 1052602W, 1052604W, 1053233W, 1053320W, 1054384W, 1054386W, 1054388W, 1054876W, 1054878W, 1054880W, 1054882W, 1054884W, 1055573W, 1055859W, 1056171W, 1061146W, 1062420W, 1062422W, 1062424W, 1062426W, 1063607W, 1063609W, 1063611W, 1063613W, 1063615W, 1063617W, 1063619W, 1064200W, 1064202W, 1064204W, 1064206W, 1064208W, 1064210W, 1064212W, 1065480W, 1065482W, 1065484W, 1065886W, 1065888W, 1066276W, 1067043W, 1067047W, 1067049W, 1067051W, 1067731W, 1067735W, 1068328W, 1069186W, 1070532W, H5967258, H5967772, H5969833, H5971306, H5974320, H5978126, H5979314, H5980562, H5985536, H5986047, H5989315, H5991474, H5993603, H5995533, H5996160, H5998668, H5998674, H5999515, H6000802, H6002928, H6005532, H6008224, H6008227, H6008684, H6008687, H6011078, H6017927, H6018624, H6021750, H6022943, H6023883, H6024773, H6024777, H6028242, H6028244, H6028247, H6030174, H6031557, H6031560, H6031562, H6036195, H6041821); 00763000529581 (0868233W, 0869699W, 0870553W, 0870555W, 0870557W, 0881326W, 0881328W, 0895574W, 0895576W, 0898382W, 0902366W, 0904724W, 0906158W, 0907660W, 0910210W, 0914586W, 0920061W, 0920063W, 0922035W, 0922037W, 0922965W, 0924475W, 0929166W, 0931920W, 0933083W, 0944351W, 0947408W, 0948526W, 0950152W, 0951520W, 0952758W, 0952760W, 0954070W, 0954072W, 0955358W, 0957559W, 0959046W, 0959048W, 0969069W, 0974335W, 0974337W, 0980766W, 0980770W, 0982545W, 0983626W, 0983628W, 0987665W, 0992011W, 0993276W, 1002459W, 1002461W, 1002463W, 1002465W, 1005204W, 1008582W, 1008586W, 1008590W, 1008594W, 1008596W, 1010272W, 1010276W, 1011065W, 1021481W, 1021483W, 1023318W, 1023326W, 1025164W, 1025166W, 1026835W, 1033176W, 1033938W, 1033940W, 1035171W, 1036764W, 1051408W, 1051410W, 1051738W, 1052604W, 1053233W, 1053320W, 1054386W, 1054388W, 1054878W, 1054880W, 1054882W, 1055573W, 1061146W, 1062422W, H5967258, H5974320, H5978126, H5980562, H5991474, H6000802, H6008687, H6021750, H6028244, H6031557, H6031562, 0871616W, 1033944W, 1052442W); N/A (1008592W). 4. Model Number: 6068096. GTIN (Lot Numbers): 00763000246730 (0831758W, 0836198W, 0836200W, 0836202W, 0837733W, 0842805W, 0844111W, 0848628W, 0849622W, 0852137W, 0852139W, 0854455W, 0855326W, 0860488W, 0860490W, 0862457W, 0864032W, 0864038W, 0871620W, 0872100W, 0873208W, 0881015W, 0881332W, 0885962W, 0885964W, 0887344W, 0887346W, 0887348W, 0888803W, 0889940W, 0891965W, 0893342W, 0893344W, 0898384W, 0900779W, 0901198W, 0901200W, 0902368W, 0903368W, 0904726W, 0906160W, 0907662W, 0910212W, 0910214W, 0914588W, 0914590W, 0917668W, 0920065W, 0920067W, 0924477W, 0929168W, 0929170W, 0931962W, 0935296W, 0935298W, 0935300W, 0936468W, 0937876W, 0937878W, 0939332W, 0940215W, 0940217W, 0942914W, 0943493W, 0945703W, 0947410W, 0948528W, 0950154W, 0951522W, 0952762W, 0952764W, 0954074W, 0954076W, 0955362W, 0955364W, 0955510W, 0957561W, 0957563W, 0959050W, 0959052W, 0959439W, 0959441W, 0959443W, 0961526W, 0961528W, 0967361W, 0968362W, 0968364W, 0968366W, 0969281W, 0973089W, 0974339W, 0974341W, 0976748W, 0977732W, 0986512W, 0987044W, 0987046W, 0987669W, 0988253W, 0988255W, 0988257W, 0989571W, 0989573W, 0990966W, 0992015W, 1002467W, 1002469W, 1002471W, 1002619W, 1003608W, 1003610W, 1003612W, 1003614W, 1004298W, 1004300W, 1004302W, 1004304W, 1004306W, 1004308W, 1004312W, 1004314W, 1005206W, 1005208W, 1006070W, 1006262W, 1007176W, 1007178W, 1007180W, 1007182W, 1007585W, 1007587W, 1007589W, 1007591W, 1007593W, 1007595W, 1007597W, 1007599W, 1007601W, 1009619W, 1010501W, 1010503W, 1010505W, 1010507W, 1011398W, 1011400W, 1011908W, 1011910W, 1012758W, 1013105W, 1016364W, 1016366W, 1016368W, 1016370W, 1016372W, 1016374W, 1016376W, 1017298W, 1017477W, 1017479W, 1017531W, 1017533W, 1017535W, 1017537W, 1017539W, 1018238W, 1018240W, 1018668W, 1018670W, 1018672W, 1018674W, 1018676W, 1018678W, 1018680W, 1018682W, 1019451W, 1019453W, 1019455W, 1020220W, 1020222W, 1020523W, 1020525W, 1021485W, 1021777W, 1022754W, 1022756W, 1022758W, 1022760W, 1023328W, 1023330W, 1024239W, 1024241W, 1024243W, 1026253W, 1031335W, 1031684W, 1031686W, 1031688W, 1032070W, 1032587W, 1032589W, 1033178W, 1033950W, 1034586W, 1035173W, 1036546W, 1036548W, 1036550W, 1036552W, 1037697W, 1037699W, 1037701W, 1037703W, 1037705W, 1037707W, 1037709W, 1037711W, 1038216W, 1038218W, 1038737W, 1039196W, 1039198W, 1047402W, 1047404W, 1048896W, 1048898W, 1048900W, 1049718W, 1049720W, 1049724W, 1049726W, 1049728W, 1049730W, 1049732W, 1049734W, 1050594W, 1050596W, 1050600W, 1051177W, 1051179W, 1058112W, 1058114W, 1058813W, 1058815W, 1058817W, 1059287W, 1059289W, 1060044W, 1060046W, 1060048W, 1060764W, 1060766W, 1060768W, 1060770W, 1060772W, 1067053W, 1067737W, 1068330W, 1068332W, H5956283, H5960953, H5964135, H5965898, H5966475, H5970317, H5970760, H5984641, H5989733, H5991687, H5991705, H5991988, H5993392, H5995463, H5998258, H5998282, H6004896, H6009876, H6010856, H6011481, H6012334, H6012339, H6012341, H6012342, H6015369, H6016337, H6021548, H6021637, H6021638, H6022792, H6037264, H6040370, H6044520, H6044521, H6046120, H6048318, H6049015, H6049835, H6049839, H6049845, H6051267, H6052448, H6053451, H6054112, H6055379, H6056422, H6056423, H6060611, H6066196, H6066198, H6067909, H6067910); 00763000529598(0862457W, 0864032W, 0864038W, 0871620W, 0872100W, 0873208W, 0881015W, 0898384W, 0902368W, 0903368W, 0935296W, 0935300W, 0937878W, 0939332W, 0943493W, 0951522W, 0952762W, 0952764W, 0954074W, 0954076W, 0955362W, 0955364W, 0957561W, 0959050W, 0959052W, 0959441W, 0973089W, 0988257W, 0989571W, 1003610W, 1003612W, 1007182W, 1050596W, 1051177W, 0864036W, 0873210W, 1004310W, 1007184W); N/A (1017479W). 5. Model Number: 6068113. GTIN (Lot Numbers): 00763000246754 (0831760W, 0836204W, 0837735W, 0839599W, 0841051W, 0842331W, 0844117W, 0846537W, 0847978W, 0849572W, 0849574W, 0868237W, 0870559W, 0874510W, 0879893W, 0885966W, 0887350W, 0888805W, 0896962W, 0898386W, 0900781W, 0901202W, 0902370W, 0903370W, 0905342W, 0910216W, 0922967W, 0924479W, 0927268W, 0929172W, 0939334W, 0951524W, 0952501W, 0952766W, 0954078W, 0957565W, 0957567W, 0961530W, 0962776W, 0968368W, 0969283W, 0973091W, 0976750W, 0977734W, 0995692W, 0997492W, 0997494W, 0997496W, 0999005W, 1000102W, 1002992W, 1006264W, 1031690W, 1032322W, 1032591W, 1033180W, 1033182W, 1033184W, 1033186W, 1033188W, 1033190W, 1033952W, 1033954W, 1041300W, 1041302W, 1041981W, 1041983W, 1041985W, 1041987W, 1042973W, 1042975W, 1042977W, 1042979W, 1043692W, 1050520W, 1051181W, 1052606W, 1052608W, 1064945W, 1064947W, 1067055W, 1067059W, H5959856, H5960023, H5976169, H5979255, H5980559, H5982391, H5995538, H5997547, H6018332, H6024477, H6030932, H6031564, H6035714, H6046424); 00763000529604 (0836204W, 0849572W, 0868237W, 0870559W, 0874510W, 0885966W, 0888805W, 0896962W, 0900781W, 0922967W, 0924479W, 0927268W, 0929172W, 0951524W, 0952766W, 0957565W, 0957567W, 0961530W, 0973091W, 0976750W, 1000102W, 1031690W, 1032591W, 1033954W, 1041300W, 1041981W, 1041983W, 1041987W, 1042977W, 1042979W, 1043692W, H5976169, H5980559, H5997547, 0854457W, 0857971W). 6. Model Number: 6068116. GTIN (Lot Numbers): 00763000246761 (0831762W, 0837093W, 0837737W, 0845005W, 0845007W, 0850844W, 0853143W, 0854459W, 0858932W, 0861112W, 0862459W, 0864040W, 0874512W, 0875981W, 0881017W, 0881334W, 0881336W, 0888807W, 0891967W, 0893346W, 0896964W, 0896966W, 0898388W, 0905344W, 0906452W, 0910218W, 0914592W, 0914594W, 0920069W, 0926363W, 0927270W, 0929174W, 0931964W, 0937880W, 0939336W, 0942916W, 0943495W, 0945705W, 0951526W, 0952503W, 0952768W, 0952770W, 0955366W, 0957569W, 0957571W, 0959054W, 0964248W, 0964250W, 0965516W, 0973093W, 0976752W, 0976754W, 0976756W, 0977736W, 0978661W, 0983632W, 0987048W, 0989575W, 0994928W, 0995694W, 1011075W, 1011402W, 1012052W, 1012054W, 1012056W, 1012058W, 1012760W, 1012762W, 1012764W, 1012766W, 1013107W, 1013109W, 1013111W, 1013113W, 1013115W, 1013117W, 1013119W, 1013121W, 1014076W, 1016378W, 1016380W, 1016382W, 1039200W, 1039202W, 1039822W, 1039824W, 1040470W, 1040492W, 1040633W, 1040635W, 1040637W, 1040639W, 1040641W, 1041304W, 1041306W, 1041308W, 1041989W, 1041991W, 1041993W, 1041995W, 1041997W, 1051522W, 1052610W, 1053235W, 1053237W, 1053239W, 1053342W, 1054390W, 1054392W, 1054394W, 1061148W, 1061150W, 1062428W, 1062430W, 1062432W, 1066280W, 1066282W, 1066284W, H5969398, H5972674, H5975979, H5976386, H5976707, H5979718, H5985104, H5991292, H5993488, H5996970, H6007862, H6011074, H6015364, H6022791, H6025215, H6025218, H6042906, H6043292, H6050290, H6051116, H6053616, H6055646); 00763000529611 (0874512W, 0875981W, 0881017W, 0881334W, 0881336W, 0891967W, 0898388W, 0905344W, 0929174W, 0952770W, 0957569W, 0957571W, 0959054W, 0964248W, 0965516W, 0977736W, 0987048W, 0989575W, 0994928W, 0995694W, 1013111W, 1039200W, 1053237W, 1054392W, 1061148W, H5972674, H5976707, H5985104, 0874514W). 7. Model Number: 6069073. GTIN (Lot Numbers): 00763000246785 (0831764W, 0837739W, 0837741W, 0839601W, 0839603W, 0842333W, 0849576W, 0853145W, 0854461W, 0855328W, 0857973W, 0858934W, 0862491W, 0865725W, 0874361W, 0875983W, 0877441W, 0879350W, 0879352W, 0885968W, 0887352W, 0888809W, 0889942W, 0891969W, 0896968W, 0898390W, 0900783W, 0901204W, 0901206W, 0902372W, 0903372W, 0905346W, 0907664W, 0917670W, 0917672W, 0918868W, 0918870W, 0918872W, 0918874W, 0920071W, 0920073W, 0922039W, 0922969W, 0924481W, 0939338W, 0942918W, 0943497W, 0943499W, 0945707W, 0951528W, 0952505W, 0952507W, 0952772W, 0952774W, 0955368W, 0957573W, 0960500W, 0962778W, 0962780W, 0964632W, 0965518W, 0968370W, 0969285W, 0969287W, 0976758W, 0977738W, 0978663W, 0978665W, 0983634W, 0989577W, 0989579W, 0992017W, 0993278W, 0993682W, 0994333W, 0994335W, 0994930W, 0995696W, 0999007W, 1003616W, 1003618W, 1004316W, 1004318W, 1004320W, 1007186W, 1007188W, 1009437W, 1009441W, 1009443W, 1009447W, 1009449W, 1009451W, 1009453W, 1011404W, 1011406W, 1011408W, 1011410W, 1011412W, 1011414W, 1011416W, 1012060W, 1012062W, 1012064W, 1017300W, 1017302W, 1017304W, 1017306W, 1017308W, 1017310W, 1017312W, 1018242W, 1018244W, 1018246W, 1018248W, 1018250W, 1019457W, 1019459W, 1019461W, 1019463W, 1019465W, 1019467W, 1019469W, 1035175W, 1036766W, 1036768W, 1036770W, 1036772W, 1036774W, 1036776W, 1037713W, 1037715W, 1038220W, 1038222W, 1038224W, 1038226W, 1038739W, 1038951W, 1038953W, 1038955W, 1039206W, 1039208W, 1039210W, 1039826W, 1039828W, 1039830W, 1040494W, 1040496W, 1040498W, 1040643W, 1040645W, 1040647W, 1040649W, 1048902W, 1048904W, 1048906W, 1049736W, 1049738W, 1049740W, 1049742W, 1049744W, 1050602W, 1050604W, 1050608W, 1050610W, 1050612W, 1050614W, 1051183W, 1051185W, 1051187W, 1051741W, 1051743W, 1057496W, 1058116W, 1058118W, 1058120W, 1058819W, 1058821W, 1058823W, 1058825W, 1058827W, 1058829W, 1059130W, 1060050W, 1060052W, 1060054W, 1060056W, 1060058W, 1060060W, 1060062W, 1064951W, 1065486W, 1065488W, 1065490W, 1065492W, 1065494W, 1065496W, 1065890W, 1065892W, 1065894W, 1066286W, 1066288W, 1067743W, 1067745W, 1067747W, 1067749W, 1071981W, 1071983W, 1071985W, 1071989W, H5960025, H5961680, H5962675, H5963063, H5964483, H5964903, H5966153, H5967526, H5974499, H5975996, H5976681, H5979308, H5984607, H5984805, H5985111, H5993303, H5995219, H5997146, H5997325, H6000119, H6009907, H6010342, H6010848, H6015956, H6015957, H6018341, H6018345, H6018346, H6018349, H6022886, H6022887, H6024860, H6024863, H6027581, H6028240, H6033629, H6036553, H6042589); 00763000868963 (0977738W, 0993682W, 0994335W, 0995696W, 0999007W, 1003618W, 1007186W, 1009443W, 1009447W, 1009449W, 1009453W, 1011410W, 1011412W, 1017306W, 1018242W, 1018250W, 1036774W, 1037713W, 1037715W, 1038220W, 1038224W, 1038226W, 1038739W, 1038953W, 1038955W, 1039206W, 1039208W, 1040496W, 1040498W, 1048904W, 1049736W, 1049738W, 1049740W, 1049742W, 1049744W, 1050608W, H5964903, H5966153, H5984805, H6000119, H6009907, H6010342, 1009439W, 1050606W). 8. Model Number: 6069076. GTIN (Lot Number): 00763000246792 (0831766W, 0836206W, 0837743W, 0839605W, 0839607W, 0842335W, 0842807W, 0854463W, 0856700W, 0857975W, 0861114W, 0862493W, 0865727W, 0869721W, 0870561W, 0870563W, 0870565W, 0875985W, 0881019W, 0885970W, 0885972W, 0887354W, 0887356W, 0895578W, 0896970W, 0898392W, 0900785W, 0903374W, 0905348W, 0906456W, 0907666W, 0910220W, 0910222W, 0914596W, 0914598W, 0917674W, 0918876W, 0918878W, 0920075W, 0926365W, 0926367W, 0927302W, 0931966W, 0935302W, 0935304W, 0937882W, 0937884W, 0939340W, 0942920W, 0947412W, 0947414W, 0948530W, 0950156W, 0951530W, 0954080W, 0957575W, 0959056W, 0959058W, 0959060W, 0960502W, 0960504W, 0965520W, 0969289W, 0973095W, 0974343W, 0976760W, 0976762W, 0977740W, 0982547W, 0982549W, 0995142W, 0995698W, 0997498W, 0997500W, 0997502W, 0998721W, 0999009W, 1000782W, 1000784W, 1002349W, 1002351W, 1002353W, 1002355W, 1002357W, 1005210W, 1006266W, 1007190W, 1009455W, 1009457W, 1009459W, 1012768W, 1012770W, 1012772W, 1014078W, 1014080W, 1014082W, 1014084W, 1014086W, 1014088W, 1024245W, 1024247W, 1024249W, 1025174W, 1025176W, 1025178W, 1025180W, 1025182W, 1025184W, 1026255W, 1026257W, 1026259W, 1026261W, 1030263W, 1032593W, 1032595W, 1033192W, 1040651W, 1040653W, 1040655W, 1041310W, 1041312W, 1041314W, 1041316W, 1041318W, 1041999W, 1042001W, 1042981W, 1042983W, 1042985W, 1042987W, 1042989W, 1042991W, 1042993W, 1043694W, 1043696W, 1051524W, 1051526W, 1053681W, 1053683W, 1054742W, 1054744W, 1054890W, 1054892W, 1056173W, 1056175W, 1056548W, 1056550W, 1056552W, 1057086W, 1057498W, 1057500W, 1057502W, 1058122W, 1058124W, 1063621W, 1063623W, 1064953W, 1064955W, 1064957W, 1064959W, 1064961W, 1067755W, 1067757W, H5956358, H5973087, H5975978, H5976695, H5977790, H5979741, H5980568, H5993941, H5995547, H5996600, H6002559, H6017939, H6018616, H6018617, H6018618, H6028231, H6030562, H6038010, H6038011, H6038861, H6038924, H6038927, H6041814, H6046740, H6046744, H6052034, H6052339, H6052342, H6052344, H6053190, H6054116, H6054120, H6055676, H6057303); 00763000529628 (0862493W, 0865727W, 0869721W, 0870561W, 0870563W, 0870565W, 0875985W, 0895578W, 0896970W, 0898392W, 0900785W, 0906456W, 0907666W, 0910220W, 0910222W, 0914596W, 0914598W, 0917674W, 0918876W, 0920075W, 0926365W, 0927302W, 0931966W, 0935304W, 0937882W, 0937884W, 0939340W, 0942920W, 0947412W, 0947414W, 0948530W, 0950156W, 0951530W, 0954080W, 0957575W, 0959056W, 0959058W, 0959060W, 0960502W, 0969289W, 0973095W, 0974343W, 0976760W, 0976762W, 0977740W, 0982547W, 0982549W, 0997498W, 0997500W, 0997502W, 0998721W, 0999009W, 1000782W, 1000784W, 1002349W, 1002351W, 1002353W, 1002355W, 1002357W, 1009459W, 1012772W, 1024249W, 1025176W, 1025178W, 1025182W, 1025184W, 1026257W, 1026259W, 1026261W, 1030263W, 1032593W, 1032595W, 1033192W, 1041310W, 1041316W, 1041318W, 1041999W, 1042001W, 1042991W, 1043694W, 1043696W, 1054742W, 1054744W, 1054890W, 1054892W, 1056548W, 1057498W, H5973087, H5975978, H5976695, H5977790, H5979741, H5980568, H6017939, H6018616, H6018617, H6018618, 0871642W, 0957577W, 1012774W, 1033194W, 1054888W). 9. Model Number: 6069093. GTIN (Lot Numbers): 00763000246815 (0835085W, 0836208W, 0839609W, 0841053W, 0842337W, 0844119W, 0847980W, 0848630W, 0854465W, 0857977W, 0858936W, 0861116W, 0864042W, 0864598W, 0865729W, 0868239W, 0868241W, 0868243W, 0870567W, 0874516W, 0877443W, 0885974W, 0887358W, 0887360W, 0896972W, 0898394W, 0901208W, 0905350W, 0906458W, 0910224W, 0910226W, 0918880W, 0918882W, 0920077W, 0922081W, 0923071W, 0924483W, 0951532W, 0952509W, 0954082W, 0957579W, 0957581W, 0961532W, 0962782W, 0964634W, 0969291W, 0977742W, 0977744W, 0978667W, 0982551W, 0995144W, 0995700W, 0997504W, 0998723W, 1000252W, 1005212W, 1011418W, 1012066W, 1012068W, 1012776W, 1012778W, 1014090W, 1014092W, 1014094W, 1014096W, 1014098W, 1014100W, 1023332W, 1023334W, 1024082W, 1027622W, 1027624W, 1027626W, 1027628W, 1027630W, 1028555W, 1028708W, 1028710W, 1028992W, 1028994W, 1029482W, 1029484W, 1030265W, 1031692W, 1043698W, 1043700W, 1044358W, 1044360W, 1044362W, 1044364W, 1044366W, 1045207W, 1051189W, 1060774W, 1060780W, 1060782W, 1061152W, 1061154W, 1061156W, 1061158W, 1062434W, 1062436W, 1062438W, 1063625W, 1063627W, 1063631W, 1063633W, 1064963W, 1064965W, 1064967W, 1065898W, 1065900W, 1066290W, 1068334W, 1073942W, H5960042, H5961689, H5967799, H5974501, H5974933, H5975083, H5979715, H5980972, H5991983, H5993359, H6000395, H6004895, H6010721, H6015923, H6020628, H6030549, H6031668, H6032600, H6034517
Other Recalls from Medtronic Sofamor Danek USA Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0162-2024 | Class II | Grafton DBM (Flex), Model Numbers: T42100, Demi... | Sep 26, 2023 |
| Z-0165-2024 | Class II | Grafton DBM Orthoblend, Model Numbers: a) T4412... | Sep 26, 2023 |
| Z-0166-2024 | Class II | Grafton Plus DBM Paste, Model Numbers: a) T4500... | Sep 26, 2023 |
| Z-0167-2024 | Class II | Grafton DBM Putty, Model Numbers: a) T43102, b)... | Sep 26, 2023 |
| Z-0163-2024 | Class II | Grafton DMB Matrix, Model Numbers: a) T42200, b... | Sep 26, 2023 |
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.