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AMK
DEPUY ORTHOPAEDICS, INC. · Model 1688-61-025 · UDI-DI 10603295067191
5
510(k) clearances
716
Adverse events (6 deaths)
26
Recalls
49
Facilities
Description
AMK TOTAL KNEE SYSTEM TIBIAL INSERT FIXED BEARING CONSTRAINED SIZE 4 10mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-03 | Tornier, Inc | A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incor |
| 2024-10-02 | Limacorporate S.p.A | Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery. |
| 2017-10-24 | Howmedica Osteonics Corp. | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| 2017-10-24 | Howmedica Osteonics Corp. | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| 2017-10-24 | Howmedica Osteonics Corp. | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| 2017-10-24 | Howmedica Osteonics Corp. | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| 2017-10-24 | Howmedica Osteonics Corp. | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| 2017-10-24 | Howmedica Osteonics Corp. | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| 2017-10-24 | Howmedica Osteonics Corp. | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| 2017-10-24 | Howmedica Osteonics Corp. | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.