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ALLthread PEEK-OPTIMA
Biomet Orthopedics, LLC · Model 904932P · UDI-DI 00880304510074
10
510(k) clearances
2,647
Adverse events
36
Recalls
240
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-11 | In2bones USA, LLC | Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label. |
| 2022-09-27 | Synthes (USA) Products LLC | The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the ster |
| 2022-09-27 | Synthes (USA) Products LLC | The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the ster |
| 2022-09-27 | Synthes (USA) Products LLC | The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the ster |
| 2022-09-27 | Synthes (USA) Products LLC | The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the ster |
| 2022-08-30 | Synthes (USA) Products LLC | Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larg |
| 2022-03-10 | Wright Medical Technology, Inc. | The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking. |
| 2022-02-14 | Biomet, Inc. | Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgic |
| 2022-02-14 | Biomet, Inc. | Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgic |
| 2022-02-14 | Biomet, Inc. | Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgic |
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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.