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TEMA Elbow System
LIMACORPORATE SPA · Model 9CC0.95.088 · UDI-DI 08033390151276
10
510(k) clearances
704
Adverse events (6 deaths)
26
Recalls
50
Facilities
Description
Flexible Reamer # 5
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.