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

Recall Z-0198-2015 — Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and disability due to:  Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.  Collagen disorders, and/or avascular necrosis of the femoral condyle.  Post-t

U.S. FDA — Device Enforcement · United States · 2014-10-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0198-2015
Date of alert
2014-10-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
62613813
Reported risk: Cleaning process validation failure.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.