Zimmer Biomet, Inc. recalls COMP PRIMARY STEM 8MM MINI, model # 113628
- Recall date
- June 5, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0299-2018
- 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 PRIMARY STEM 8MM MINI, model # 113628
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