Z-1716-2021 Class II Terminated
FDA device recall Z-1716-2021 was initiated by Zavation on March 25, 2021 and is designated Class II. Reason for recall: Products distributed as sterile may not have been adequately sterilized The recall status is terminated (terminated March 20, 2023). Affected quantity: 89 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 9, 2021
- Initiation Date
- March 25, 2021
- Termination Date
- March 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89 units
Product Description
10 GAUGE DIRECT ACCESS DIAMOND TIP, CODE: INTVM-DWCd. For use in Orthopedic / spinal procedures.
Reason for Recall
Products distributed as sterile may not have been adequately sterilized
Distribution Pattern
US nationwide distribution.
Code Information
Lot: 11285ZV, 2001200