RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 ite...
FDA Recall #Z-1024-2017 — Class II — December 19, 2016
Product Description
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
Reason for Recall
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.
Recalling Firm
Zimmer Biomet, Inc. — Warsaw, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
36
Distribution
USA (nationwide) and Internationally to ARGENTINA
Code Information
Item XL-108323 Lot 761680 UDI (01)00880304651524(17)210713(10)761680 Item XL-108223 Lot 419460 UDI (01)00880304651494(17)210713(10)419460
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated