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

Recall Z-2967-2018 — Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction.

U.S. FDA — Device Enforcement · United States · 2018-05-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2967-2018
Date of alert
2018-05-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Encore Medical, Lp
Product category
device
Product type
Devices
Reported risk: After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.
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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