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

Recall Z-1265-2023 — Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226

U.S. FDA — Device Enforcement · United States · 2023-02-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1265-2023
Date of alert
2023-02-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
DePuy Orthopaedics, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10603295491033
Reported risk: The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
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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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.