BEUDAMED
    FDA Recall Completed

    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

    Recall: Z-1256-2018 · Initiated January 29, 2018

    Recall

    Recall Number
    Z-1256-2018
    Event Number
    79241
    FEI Number
    1000116912
    Product Code
    KWS
    Status
    Completed
    Root Cause
    Device Design
    Initiated
    January 29, 2018
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758-5445

    Description

    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

    Reason

    It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants

    Action

    DJO Global sent an Urgent Field Safety Notice letter dated January 29, 2018, to affected customers. The letter identified the affected product, problem and actions to be taken. For questions call (512) 834-6255

    Distribution

    US Nationwide Distribution

    Quantity

    92 units