FDAFDA · Food and drugs·Recall number Z-1025-2017
Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152
Published January 25, 2017 · Recall initiated: December 19, 2016
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
Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- USA (nationwide) and Internationally to ARGENTINA
- Lot
- Item XL-200152 Lot 339260 UDI (01)00880304491366(17)210713(10)339260
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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