BEUDAMED
    FDA Recall Open, Classified

    Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3

    Recall: Z-0139-2023 · Initiated September 30, 2022

    Recall

    Recall Number
    Z-0139-2023
    Event Number
    90965
    Firm
    Wright Medical Technology, Inc.
    FEI Number
    3010667733
    Product Code
    HSN
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    September 30, 2022
    Posted
    October 27, 2022
    Address
    1023 Cherry Rd, Memphis, TN, 38117-5423

    Description

    Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3

    Reason

    The tibial tray lock detail is oversized (larger than specification).

    Action

    Stryker notified consignees on about 09/30/2022, via letter that was hand delivered or sent via email titled, "URGENT: MEDICAL DEVICE RECALL." The letter instructed consignees to check inventory and quarantine any affected product, return the enclosed response form, arrange for the return of affected product and notify all applicable parties of the recall if product was further distributed.

    Distribution

    US Nationwide distribution in the state of New York.

    Quantity

    1 unit