FDAFDA · Food and drugs·Recall number Z-1024-2017
RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners Size 23 item XL-108223
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-108323 Lot 761680 UDI (01)00880304651524(17)210713(10)761680 Item XL-108223 Lot 419460 UDI (01)00880304651494(17)210713(10)419460
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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