BEUDAMED
    FDA Recall Terminated

    Stryker Endoscopy PrepStrap Shoulder Sleeve, Model Number 3910900200, Manufactured by Stryker Endoscopy, San Jose, CA

    Recall: Z-1603-2010 · Initiated July 27, 2009

    Recall

    Recall Number
    Z-1603-2010
    Event Number
    53197
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    HST
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 27, 2009
    Posted
    May 14, 2010
    Terminated
    December 8, 2010
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    Stryker Endoscopy PrepStrap Shoulder Sleeve, Model Number 3910900200, Manufactured by Stryker Endoscopy, San Jose, CA

    Reason

    Latex-- Certain lots of Product contain undeclared latex.

    Action

    An Urgent: Device Removal notice, dated 7/27/2009 was sent to the sole distributor, Stryker Orthopaedics in New Jersey. The distributor will execute the sub-recall. The firm intends to scrap all returned product at that facility, who will provide a record of disposition. The distributor will notify consignees via a mail packet that will be sent via FedEx overnight mail. Consignees will be instructed to return all product to the distributor, with credit provided per policy.

    Distribution

    Nationwide Distribution

    Quantity

    842 units