Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls COMP 12MM HUM FRAC STEM MACRO, model # 11-113562

Recall date
June 5, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0298-2018
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
Nationwide in US; Internationally Argentina, Netherlands & Canada

Why it was recalled

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

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

What was recalled

COMP 12MM HUM FRAC STEM MACRO, model # 11-113562

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