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

Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage: indicated for use in the lateral compartment and intended to be implanted with bone cement. — recall Z-0624-2021

U.S. FDA — Device Enforcement · United States · 2020-11-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0624-2021
Date of alert
2020-11-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Biomet, Inc.
Product category
device
Product type
Devices
Reported risk: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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