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GMReis Fibula Nail System
GM DOS REIS INDUSTRIA E COMERCIO LTDA · Model Locking Screw T10 Ø3,5mm X 14,0mm · UDI-DI 07899258694900
HSB
Prescription
10
510(k) clearances
37,471
Adverse events (115 deaths)
690
Recalls
299
Facilities
Description
Locking Screw T10 Ø3,5mm X 14,0mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-16 | Smith & Nephew, Inc. | Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equ |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ |
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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.