FDA Device recall Z-1634-2015
Stryker Orthopaedics Scorpio femoral component
- FDA Device
- Class II
- terminated
- Published 2015-05-27
On 2015-05-27 the FDA classified a Class II recall of Stryker Orthopaedics Scorpio femoral component by Stryker Howmedica Osteonics, citing 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 bar….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1634-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-15 |
| Published | 2015-05-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Howmedica Osteonics |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Item number 26-3005L Lot numbers MNH0ND, MNH3V7, MNH8XR, MNHN0E, MNH6Y5; 70-3003L Lot MNE6NM; 70-3003R Lot MNE963; 70-3…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- |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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All Stryker Howmedica Osteonics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1634-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.