FDA-Device2017-01-25Class II

Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152

Zimmer Biomet, Inc.
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.

Sold states
USA (nationwide) and Internationally to ARGENTINA
Affected count
19
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1025-2017

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