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

Recall Z-1608-2024 — NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.

U.S. FDA — Device Enforcement · United States · 2024-03-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1608-2024
Date of alert
2024-03-28
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00595201501
Reported risk: Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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