BEUDAMED
    FDA Recall Open, Classified

    Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty

    Recall: Z-3309-2024 · Initiated August 29, 2024

    Recall

    Recall Number
    Z-3309-2024
    Event Number
    95245
    Firm
    Tornier, Inc
    FEI Number
    3000718467
    Product Code
    PAO
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 29, 2024
    Posted
    September 27, 2024
    Address
    10801 Nesbitt Ave S, Bloomington, MN, 55437-3109

    Description

    Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty

    Reason

    Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.

    Action

    Stryker issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 08/29/2024 via email. The notice explained the issue, potential risk, and requested the following actions be taken: Identify and isolate the affected units, and respond to the notice via email. Upon receipt of the response, Stryker will arrange for the return of the device. Those consignees who further distributed the product (to other sites or customers) were directed to notify those parties. For questions or concerns, contact: [email protected].

    Distribution

    US Nationwide distribution.

    Quantity

    38 units