Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-2...
FDA Recall #Z-1025-2017 — Class II — December 19, 2016
Product Description
Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152
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
19
Distribution
USA (nationwide) and Internationally to ARGENTINA
Code Information
Item XL-200152 Lot 339260 UDI (01)00880304491366(17)210713(10)339260
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated