Zimmer Biomet, Inc. recalls fastener, fixation, nondegradable, soft tissue
- Recall date
- October 25, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1009-2018
- FDA classification
- Class II
- Brand / firm
- Zimmer Biomet, Inc.
- Sold / distributed
- TX, NC, FL, PA, IN, WI, VA, NY, NJ, AL, CT
Why it was recalled
It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
fastener, fixation, nondegradable, soft tissue
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