Recall Z-1631-2021— BIOPSYBELL S.R.L.
Class II · Terminated
Class II FDA medical device recall by BIOPSYBELL S.R.L., initiated 2021-03-22, terminated 2026-02-17. FDA's recall record names no specific 510(k) clearance for this event. Product: BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system. Reason: Products labeled as sterile were distributed, but may not have been sterilized..
- Recalling firm
- BIOPSYBELL S.R.L.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-03-22
- Terminated
- 2026-02-17
- Firm location
- Mirandola, N/A, Italy
Product description
BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
Reason for recall
Products labeled as sterile were distributed, but may not have been sterilized.
Data sourced from openFDA. This site is unofficial and independent of the FDA.