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

Recall Z-1512-2018 — Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function

U.S. FDA — Device Enforcement · United States · 2018-01-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1512-2018
Date of alert
2018-01-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Howmedica Osteonics Corp.
Product category
device
Product type
Devices
Reported risk: Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
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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