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SMR System
LIMACORPORATE SPA · Model 1361.50.815 · UDI-DI 08033390273633
1
510(k) clearances
12,769
Adverse events (11 deaths)
68
Recalls
191
Facilities
Description
SMR System - Retentive Liner +3mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-30 | restor3d Inc. | Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws. |
| 2026-05-20 | Zimmer, Inc. | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. |
| 2026-05-20 | Zimmer, Inc. | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. |
| 2026-05-20 | Zimmer, Inc. | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. |
| 2026-05-20 | Zimmer, Inc. | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. |
| 2026-05-20 | Zimmer, Inc. | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. |
| 2026-04-30 | Medacta Usa Inc | Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are posit |
| 2026-01-15 | Encore Medical, LP | Knee and Humeral socket implants contain incorrect labeling. |
| 2025-09-05 | Exactech, Inc. | Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. |
| 2025-09-05 | Exactech, Inc. | Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. |
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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.