Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL Max…

Recall date
December 19, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1024-2017
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

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

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