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Piccolo Composite Nailing System
CARBOFIX ORTHOPEDICS LTD · Model Proximal Femur Nail · UDI-DI 07290109338293
HSB
Prescription
2
510(k) clearances
37,471
Adverse events (115 deaths)
690
Recalls
299
Facilities
Description
Nail indicated for the treatment of stable and unstable proximal femur fractures (pertrochanteric, intertrochanteric, high subtrochanteric fractures, and combinations of these fractures), including, fractures resulting from trauma, nonunions, malunions, pathological fractures, impending pathological fractures, tumor resections, and revision procedures.
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.