Recall Z-1748-2021
Zavation · initiated March 25, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
Codes / lots: Pending
Reason for recall
Products distributed as sterile may not have been adequately sterilized
FDA-determined cause: Vendor change control
Action taken
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.
Details
- Recall number
- Z-1748-2021
- Initiated
- March 25, 2021
- Terminated
- March 20, 2023
- Product code
- NDN – Cement, Bone, Vertebroplasty
- Distribution
- US nationwide distribution.
- Recalling firm
- Zavation, Flowood, MS
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1700-2021 Class II | 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1701-2021 Class II | 10 GAUGE CEMENT DELIVERY CANNULA, INTVM-CDC. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1702-2021 Class II | ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1703-2021 Class II | ZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1704-2021 Class II | ZVplasty Direct Access Diamond Tip Trocar, 10 Gauge, REF VCF-1023. For use in Orthopedic…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1705-2021 Class II | ZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK. For use in…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1706-2021 Class II | ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1707-2021 Class II | ZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula, REF VCF-DDSKbd. For…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1708-2021 Class II | ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DSBAK. For…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1709-2021 Class II | ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1710-2021 Class II | ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For use in…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1711-2021 Class II | ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1712-2021 Class II | ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1713-2021 Class II | ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1714-2021 Class II | 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKbd. For use in…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1715-2021 Class II | 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1716-2021 Class II | 10 GAUGE DIRECT ACCESS DIAMOND TIP, CODE: INTVM-DWCd. For use in Orthopedic / spinal…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1717-2021 Class II | 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1718-2021 Class II | 10 GAUGE CEMENT DELIVERY CANNULA, CODE: INTVM-CDC. For use in Orthopedic / spinal…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1719-2021 Class II | 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in Orthopedic /…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1720-2021 Class II | 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. For use in…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1721-2021 Class II | ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1722-2021 Class II | ZVplasty Biopsy Device, 10 Gauge, REF VCF-1010. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1723-2021 Class II | ZVplasty Biopsy Device, 11 Gauge, REF VCF-1010-11. For use in Orthopedic / spinal…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1724-2021 Class II | ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1725-2021 Class II | ZVplasty Directional Cement Cannula Long, REF VCF-1080-L. For use in Orthopedic / spinal…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1726-2021 Class II | ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For use in…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1727-2021 Class II | 10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1728-2021 Class II | ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1729-2021 Class II | ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |