Zimmer Biomet, Inc. recalls Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical pro…
- Recall date
- February 28, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1081-2019
- FDA classification
- Class II
- Brand / firm
- Zimmer Biomet, Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Lack of an adequate sterilization validation
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 414989
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