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

Recall Z-1009-2018 — fastener, fixation, nondegradable, soft tissue

U.S. FDA — Device Enforcement · United States · 2017-10-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1009-2018
Date of alert
2017-10-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer Biomet, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
110019010
Reported risk: It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break 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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