Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152

Recall date
December 19, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1025-2017
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
USA (nationwide) and Internationally to ARGENTINA

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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