BEUDAMED
    FDA Recall Open, Classified

    AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101

    Recall: Z-2019-2023 · Initiated June 12, 2023

    Recall

    Recall Number
    Z-2019-2023
    Event Number
    92520
    Firm
    Tornier, Inc
    FEI Number
    3000718467
    Product Code
    KWS
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 12, 2023
    Posted
    June 28, 2023
    Address
    10801 Nesbitt Ave S, Bloomington, MN, 55437-3109

    Description

    AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101

    Reason

    A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa.

    Action

    Tornier issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees beginning on 06/12/2023 by email and letter. The notice explained the problem, the risk associated with its use, and requested that the affected devices be isolated/quarantined pending return. Distributors were directed to notify their customers.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, United Kingdom.

    Quantity

    55 units