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Fixion Nailing System
CARBOFIX ORTHOPEDICS LTD · Model Interlocking Tibial Nail · UDI-DI 07290109330976
HSB
Prescription
10
510(k) clearances
37,471
Adverse events (115 deaths)
690
Recalls
299
Facilities
Description
The interlocking intramedullary nail is intended for use in fixation of various types of fractures, including diaphyseal fractures and short distal or proximal fragments in the long bones. Includes nail cap.
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.