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

Recall Z-0452-2019 — Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.

U.S. FDA — Device Enforcement · United States · 2018-10-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0452-2019
Date of alert: 2018-10-02
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Zimmer Biomet, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 816712165

Reported risk: The set screw is not able to advance or reverse from the original position in the nail.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-0452-2019 — Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.

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