Recall Z-1635-2021 ยท LOD Bone Cement
BIOPSYBELL S.R.L.
CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051
| Date | May 19, 2021 (initiated Mar 22, 2021) |
| Status | Terminated |
| Reason | Products labeled as sterile were distributed, but may not have been sterilized. |
| Root cause | Vendor change control |
| Action | The firm notified two consignees with the preliminary information by email on 03/22/2021 and followed with the official notice with the complete information on 04/08/2021 to all consignees. The letter requested that the consignee cease using the affected product and contact Biopsybell or a Biopsybell representative for product return/disposal and related replacement. Distributors were directed to identify those who received the product and notify them. |
| Quantity | 500 units |
| Distribution | US Nationwide distribution in the states MS and KY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.