Zavation recalls ZVplasty System, 20mm, Part# VCF-1020-2. For use in Orthopedic / spinal procedures.
- Recall date
- March 25, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1766-2021
- FDA classification
- Class II
- Brand / firm
- Zavation
- Sold / distributed
- US nationwide distribution.
Why it was recalled
Products distributed as sterile may not have been adequately sterilized
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ZVplasty System, 20mm, Part# VCF-1020-2. For use in Orthopedic / spinal procedures.
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