Z-0145-2022 Class II Terminated
FDA device recall Z-0145-2022 was initiated by ADRIA SRL on May 17, 2021 and is designated Class II. Reason for recall: The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed. The recall status is terminated (terminated November 6, 2023). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- October 27, 2021
- Initiation Date
- May 17, 2021
- Termination Date
- November 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745
Reason for Recall
The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
Distribution Pattern
The products were distributed to the following US states: NJ and NY.
Code Information
Lot Number: ZV0994 AD0314/20 AD0316/20