Z-1752-2021 Class II Terminated
FDA device recall Z-1752-2021 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: 178 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
- 178 units
Product Description
InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. 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
a) INTVM-15-FLDSK, Lot Numbers:10342ZV, 12525ZV, 12267ZV, 12011ZV, 10545ZV, 10048ZV, 11861ZV, 11343ZV, 11037ZV, 10780ZV, 11102ZV b) INTVM-20-FLDSK, Lot Numbers: 10312ZV, 11698ZV, 10276ZV, 10205ZV, 10031ZV