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

Recall Z-0493-2014 — G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000

U.S. FDA — Device Enforcement · United States · 2013-11-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0493-2014
Date of alert
2013-11-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Biomet, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
010001000
Reported risk: Investigation identified that the outer label, inner label, and patient label all have the incorrect diameter size of 10.5mm. The screw is actually a 6.5mm diameter and correctly corresponds to the items number on the label.
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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