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

Recall Z-0617-2021 — 4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009810, 110009821, 110009825, 110009852 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.

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-0617-2021
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
Barcode (EAN/GTIN)
110009810
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.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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