Device product
Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749
Z-0146-2022
Product summary
- Firm
- ADRIA SRL
- Event
- Event 88543
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0146-2022
Official wording
Reason: The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
Code information: Lot Number: AD0063/20 AD0313/20 AD0302/20
Distribution pattern: The products were distributed to the following US states: NJ and NY.
Derived failure modes
-
Unknown
The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.