Device product
10 GAUGE DIRECT ACCESS DIAMOND TIP, CODE: INTVM-DWCd. For use in Orthopedic / spinal procedures.
Z-1716-2021
Product summary
- Firm
- Zavation
- Event
- Event 87661
- Status
- Terminated
- Classification
- Class II
- Quantity
- 89 units
- Official record key
device-enforcement:Z-1716-2021
Official wording
Reason: Products distributed as sterile may not have been adequately sterilized
Code information: Lot: 11285ZV, 2001200
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Sterility assurance
may not have been adequately sterilized