Mirandola, N/A, Italy
BIOPSYBELL S.R.L. recalls
1 recall recorded since 2018, most recently on 22 March 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 22 March 2021
- Terminated
- 17 February 2026
- Reason
- Products labeled as sterile were distributed, but may not have been sterilized.
- Distribution
- US Nationwide distribution in the states MS and KY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1631-2021, Z-1641-2021, Z-1644-2021, Z-1635-2021, Z-1632-2021, Z-1639-2021, Z-1634-2021, Z-1637-2021, Z-1647-2021, Z-1640-2021, Z-1649-2021, Z-1633-2021 and 7 more
- BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
- 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK
- 11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK
- CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051
- RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US
- 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK
- BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111
- 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD
- and 11 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.