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

Recall Z-1816-2016 — Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessories

U.S. FDA — Device Enforcement · United States · 2016-04-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1816-2016
Date of alert
2016-04-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Biomet, Inc.
Product category
device
Product type
Devices
Reported risk: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
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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