BEUDAMED
    FDA Recall Terminated

    Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set

    Recall: Z-2245-2018 · Initiated March 5, 2018

    Recall

    Recall Number
    Z-2245-2018
    Event Number
    79754
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    FSM
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 5, 2018
    Terminated
    February 28, 2020
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set

    Reason

    Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.

    Action

    On March 8, 2018, the recalling firm sent Urgent Product Recall letters to its customers to inform them of the recall. Customers were advised to take the following actions: 1. Immediately review their inventory to identify and quarantine all affected products listed above in a manner that ensures the affected products will not be used. 2. Complete the Verification Section and send a copy to the recalling firm. 3. Forward this notice to anyone in the facility that needs to be informed. 4. If any of the affected products have been forwarded to another facility, contact that facility to arrange return. Customers with questions were advised to call 610-719-5450, 8AM-5PM (EST), Monday through Friday, or contact their DePuy Synthes sales consultant.

    Distribution

    Distributed to accounts in CA, IL, IN, KS, LA, MD, NC, NE, NJ, OR, TX, and VA. Foreign distribution to Canada.

    Quantity

    7