Zimmer Biomet, Inc. recalls Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1040-12 Used for the re-att…
- Recall date
- August 22, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0398-2019
- FDA classification
- Class II
- Brand / firm
- Zimmer Biomet, Inc.
- Sold / distributed
- Worldwide distribution: US Nationwide, Canada Argentina Australia Belgium Brazil Chile Colombia Costa Rica Czech Republic Dominican Republic Ecuador Finland France China Ecuador Germany Greece Hong Kong Indonesia Italy Japan Jordan Korea Lebanon Malaysia Netherland Paraguay Peru Singapore South Afr…
Why it was recalled
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
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 Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1040-12 Used for the re-attachment of the bone flap after a craniotomy.
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