Zimmer Biomet, Inc. recalls Dual Mobility Vivacit-E Bearing, Model Number 110031009
- Recall date
- August 14, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0057-2021
- FDA classification
- Class II
- Brand / firm
- Zimmer Biomet, Inc.
- Sold / distributed
- Products were distributed to the following US states: FL, ID, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, OR, PA, SC, TX, UT, VA, WI, and WV.
Why it was recalled
The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Dual Mobility Vivacit-E Bearing, Model Number 110031009
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