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

Recall Z-2732-2024 — Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;

U.S. FDA — Device Enforcement · United States · 2024-08-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2732-2024
Date of alert
2024-08-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Howmedica Osteonics Corp.
Product category
device
Product type
Devices
Reported risk: A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
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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