FDAFDA · Food and drugs·Recall number Z-0301-2018
CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064
Published January 10, 2018 · Recall initiated: June 5, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- Nationwide in US; Internationally Argentina, Netherlands & Canada
- Lot
- Lot Number: 854540
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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