BIOPSYBELL S.R.L. recalls BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US
- Recall date
- March 22, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1633-2021
- FDA classification
- Class II
- Brand / firm
- BIOPSYBELL S.R.L.
- Sold / distributed
- US Nationwide distribution in the states MS and KY.
Why it was recalled
Products labeled as sterile were distributed, but may not have been 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
BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US
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