Recall Z-1756-2021 ยท NDN Cement, Bone, Vertebroplasty
Zavation
OsteoFlex BONE CEMENT, REF Numbers: a) INTV-OSFL b) INTV-OSFL-LV. For use in Orthopedic / spinal procedures.
| Date | Mar 25, 2021 |
| Status | Terminated |
| Reason | Products distributed as sterile may not have been adequately sterilized |
| Root cause | Vendor change control |
| Action | Zavation initially notified their consignees of the problem by email beginning on 03/24/2021 and requested they quarantine the product. The firm sent a subsequent email beginning on 04/13/2021 requesting the return of the product. The recall is being conducted to the user level. |
| Quantity | 200 units |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.