Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0972-2026 — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Right, Trochanteric Nail Component: N/A

U.S. FDA — Device Enforcement · United States · 2025-12-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0972-2026
Date of alert
2025-12-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
815509420
Reported risk: 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 occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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