Device product
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. For use in Orthopedic / spinal procedures.
Z-1720-2021
Product summary
- Firm
- Zavation
- Event
- Event 87661
- Status
- Terminated
- Classification
- Class II
- Quantity
- 122 units
- Official record key
device-enforcement:Z-1720-2021
Official wording
Reason: Products distributed as sterile may not have been adequately sterilized
Code information: Lot: 20051290, 20081943, 20061420, 2002439
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Sterility assurance
may not have been adequately sterilized