Z-1710-2021 Class II Terminated

Recalled by Zavation — Flowood, MS

FDA device recall Z-1710-2021 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: 1 unit.

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
1 unit

Product Description

ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. 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: 19123174