Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp., A subsidiary of Stry...
FDA Device Recall #Z-1634-2015 — Class II — August 15, 2014
Recall Summary
| Recall Number | Z-1634-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 15, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Howmedica Osteonics Corp. |
| Location | Mahwah, NJ |
| Product Type | Devices |
| Quantity | 1,147 in total |
Product Description
Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint.
Reason for Recall
The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.
Distribution Pattern
Worldwide Distribution: US (nationwide) including PR and countries of: Australia, Canada, China, Brazil, France, Hong Kong, India, Italy, Mexico, Netherlands, Singapore, South Africa, Sweden, and Spain.
Lot / Code Information
Item number 26-3005L Lot numbers MNH0ND, MNH3V7, MNH8XR, MNHN0E, MNH6Y5; 70-3003L Lot MNE6NM; 70-3003R Lot MNE963; 70-3007L Lots MNE58K, MNE6HL, MNE8MN, MNEKXP; 70-3007R Lots MNEV2Y, MNEVDV, MNEN3D, MNEX43; 70-3013L Lot MMMXTY; 70-4104L Lots MNE0Y8, MNE2J2, MND743, MNDVDT; 71-3009L Lots MNE12D, MNEALW, MNEEE4, MNEXLK, MNEXV0; 71-3009R Lots MNELHM, MNEYNE; 71-3013L Lot MMR24J; 71-4104L Lot MMAKXS; 71-4503R Lots MMT7P8, MMT8J3, MNDKJ7; 71-4504L Lots MNE5D4, MNEHV1; 71-4504R Lots MND272, MNDD9D, MNEL8W; 71-4505L Lots MMT4KY, MMTPHS, MNAJ78, MNAN2L, MNDP2N; 71-4505R Lots MMTEW1, MNA062, MNANVA; 71-4506L Lots MNAJ1W, MNARAR, MNEL1Y, MNEW53; 71-4507L Lots MMT971, MMT9R5X1, MMTJRT, MNALJA, MND1V8; 71-4507R Lots MNA17E, MND4WP, MNEAAD, MNEM55; 71-4509R Lots MMR2HL, MND9AE; 80-4403L Lots MNE0LE, MNEJ70, MNEK3L; 80-4404R Lot MNHTRK, 80-4405L Lot MNERD1; 80-4405R Lots MNEEND, MNEHNO, MNEK42, MNEMNR, MNEMXH, MNEY4A; 80-4406L Lots MNA4HR, MNEH40, MNE37L, MNE769, MNE9RD, MNEATP, MNEX06, MNEXA8; 80-4407R Lots MNELAL, MNEP9K, MNEPVE; 80-4408L Lot MNEX9T; 80-4409L Lots MNE7H9, MNEDWK, MNEDXN; 80-4409R Lots MNE0R2, MNETXP, MNEVTV; 80-4411L Lots MNEN81, MNEWN4; 80-6404R Lot MNDKD0; 80-6405R Lots MMTA8L, MNA175; 80-6407L Lot MMRV9D; 80-6411L Lot MMP7TS; 81-4404R Lots MNE34H, MNE9WN, MNEKY7; 81-4405L Lots MNE3XK, MNE4OR, MNE473, MNE50T, MNE6A5, MNE7NN, MNE9DD, MNEDX6, MNEJ0N, MNELK5, MNERR2; 81-4405R Lots MNE5PE, MNE5W5, MNEA1T, MNEH09, MNEK9M, MNEP17, MNEPET, MNEPX6, MNER3V, MNEWW7, MNEXDP, MNEXLL, MNEY3R; 81-4406L Lots MNE0J3, MNE5D6, MNEA42, MNEHL1, MNEM0H, MNEMD4, MNEMJ8, MNEMPD, MNENAR, MNEPN6, MNEW72; 81-4406R Lots MNE1XK, MNE5D2, MNEA75, MNED3A, MNEVLY, MNEYHH; 81-4407L Lots MNE127, MNE26L, MNE3KJ, MNE63T, MNE6XK, MNE71T, MNE8PT, MNE996, MNEPYY; 81-4407R Lots MMPE33, MNEOJ9, MNE217, MNE2NH, MNE3MH, MNE525, MNE5YP, MNE6WT, MNE7V2, MNE9J1, MNEA62, MNEAR2, MNEAXJ, MNED83, MNENNE, MNELEP, MNENM4, MNENY7, MNEPEP, MNERAV, MNETYX, MNEVN7, MNEW3Y, MNEW56, MNEWN0, MNEX5E, MNEXV1, MNEXVT, MNEY27, MNEYR6, MNHTW5; 81-4408L Lots MNE2VE, MNEAMY, MNEEM0, MNEYRT, MNEYYK; 81-4408R Lots MNEO89, MNE2A1, MNE4DK, MNE7XV, MNE8N4, MNE9M9, MNEA4T, MNEAJ8, MNEMLA, MNET9J; 81-4409L Lots MNE4W5, MNE93H, MNEEEN, MNEVOY, MNEY57, MNEY74, MNE159, MNE1H2, MNE2DK, MNEM2D, MNENLJ, MNER77, MNEV0J; 81-4411R Lot MMTVXW; 81-4413L Lot MMP0MP; 81-6404R Lot MMTR58; 81-6407L Lot MMTDN7.
Other Recalls from Stryker Howmedica Osteonics Corp.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2160-2017 | Class II | Hoffmann LRF Safety Clip (Bone Transport Strut)... | Apr 26, 2017 |
| Z-1020-2017 | Class II | Reunion TSA Peg Alignment Sound Catalog #5901... | Dec 2, 2016 |
| Z-0880-2017 | Class II | GAM Kirschner Wire, Sterile R, T2 K-Wire, Steri... | Nov 9, 2016 |
| Z-0378-2017 | Class II | LFIT Anatomic V40 Femoral Head, Low Friction Io... | Aug 29, 2016 |
| Z-0060-2017 | Class II | Stryker Orthopaedics Universal Acetabular Cup P... | Aug 18, 2016 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
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.