BEUDAMED
    FDA Recall Terminated

    InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK c) INTVM-15-DSK d) INTVM-15-DSKC e) INTVM-15-SBK f) INTVM-15-SIKBC g) INTVM-20-DSK h) INTVM-20-SBK. For use in Orthopedic / spinal procedures.

    Recall: Z-1751-2021 · Initiated March 25, 2021

    Recall

    Recall Number
    Z-1751-2021
    Event Number
    87661
    Firm
    Zavation
    FEI Number
    3008583793
    Product Code
    NDN
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    March 25, 2021
    Terminated
    March 20, 2023
    Address
    220 Lakeland Pkwy, Flowood, MS, 39232-9552

    Description

    InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK c) INTVM-15-DSK d) INTVM-15-DSKC e) INTVM-15-SBK f) INTVM-15-SIKBC g) INTVM-20-DSK h) INTVM-20-SBK. For use in Orthopedic / spinal procedures.

    Reason

    Products distributed as sterile may not have been adequately sterilized

    Action

    Zavation initially notified their consignees of the problem by email beginning on 03/24/2021 and requested they quarantine the product. The firm sent a subsequent email beginning on 04/13/2021 requesting the return of the product. The recall is being conducted to the user level.

    Distribution

    US nationwide distribution.

    Quantity

    503 units