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

Recall Z-1948-2015 — Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.

U.S. FDA — Device Enforcement · United States · 2014-10-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1948-2015
Date of alert
2014-10-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
11011448
Reported risk: Failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity. If the outer tray is compromised in addition to the inner tray a periprosthetic infection may occur. The risk associated with a periprosthetic infection is a revision or potential multi-stage revision to treat the infection.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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