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

Recall Z-2115-2017 — NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.

U.S. FDA — Device Enforcement · United States · 2017-04-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2115-2017
Date of alert
2017-04-28
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer Biomet, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
63463357
Reported risk: Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorrect.
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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