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SMR Shoulder
LIMACORPORATE SPA · Model 9013.75.367 · UDI-DI 08033390167321
10
510(k) clearances
1,564
Adverse events (2 deaths)
20
Recalls
96
Facilities
Description
Sleeve for Angled Glenoid Reamer - 15°
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-03 | ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY | Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may le |
| 2023-08-29 | Limacorporate S.p.A | Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw moving from its origina |
| 2023-05-30 | Limacorporate S.p.A | Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. |
| 2023-05-30 | Limacorporate S.p.A | Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. |
| 2023-02-21 | Limacorporate S.p.A | Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the |
| 2022-01-07 | Biomet, Inc. | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion stre |
| 2022-01-07 | Biomet, Inc. | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion stre |
| 2022-01-07 | Biomet, Inc. | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion stre |
| 2022-01-07 | Biomet, Inc. | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion stre |
| 2022-01-07 | Biomet, Inc. | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion stre |
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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.