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Piccolo Composite Nailing System

CARBOFIX ORTHOPEDICS LTD · Model Ankle Arthrodesis Nail · UDI-DI 07290109335568

HSB Prescription
2
510(k) clearances
37,471
Adverse events (115 deaths)
690
Recalls
299
Facilities

Description

An ankle arthrodesis nail indicated for tibiotalocalcaneal arthrodesis (fusion). Specific indications include: Avascular necrosis of the talus; Failed total ankle arthroplasty; Trauma (malunited tibial pilon fracture); Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease; Revision ankle arthrodesis; Neuroarthropathy; Rheumatoid arthritis; Osteoarthritis; Pseudoarthrosis; Post-traumatic arthrosis; Previously infected arthrosis; Charcot foot; Severe endstage degenerative arthritis; Severe defects after tumor resection; Pantalar arthrodesis

Recalls

DateFirmReason
2026-03-16Smith & 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
2025-12-02Zimmer, 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
2025-12-02Zimmer, 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
2025-12-02Zimmer, 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
2025-12-02Zimmer, 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
2025-12-02Zimmer, 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
2025-12-02Zimmer, 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
2025-12-02Zimmer, 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
2025-12-02Zimmer, 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
2025-12-02Zimmer, 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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Data 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.