BEUDAMED
    FDA Recall Terminated

    Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, Soft Eyelet Anchor, manufactured by Stryker Endoscopy, Puerto Rico

    Recall: Z-0618-2011 · Initiated August 20, 2009

    Recall

    Recall Number
    Z-0618-2011
    Event Number
    53182
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    August 20, 2009
    Posted
    December 14, 2010
    Terminated
    December 14, 2010
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, Soft Eyelet Anchor, manufactured by Stryker Endoscopy, Puerto Rico

    Reason

    Potential breakage -- product may break while inserting it into the bone during surgery. This may prolong surgery, or, if undetected during surgery, result in retained fragments that may cause metal sensitization or immune response, or necessitate further intervention to retrieve the titanium fragments.

    Action

    Stryker issued an Urgent Device Removal notification letter dated August 21, 2009 to consignees. Consignees were asked to acknowledge receipt and distribute the letter, track reponses, and destroy any returned material and document through weekly summary and records. Stryker can be contacted at 408 754-2000 about this recall.

    Distribution

    Nationwide Distribution: to one distributor in NJ.

    Quantity

    447 units