BEUDAMED
    FDA Recall Terminated

    Stryker Wedge HS Suture Anchor II with Needles, 6.5 mm, Model number 3910-100-145 Intended for use in securing soft tissue to bone in certain procedures in specific areas.

    Recall: Z-1538-2008 · Initiated February 7, 2008

    Recall

    Recall Number
    Z-1538-2008
    Event Number
    46916
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    MBI
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    February 7, 2008
    Posted
    August 6, 2008
    Terminated
    December 21, 2010
    Address
    5900 Optical Ct, San Jose, CA, 95138

    Description

    Stryker Wedge HS Suture Anchor II with Needles, 6.5 mm, Model number 3910-100-145 Intended for use in securing soft tissue to bone in certain procedures in specific areas.

    Reason

    Product package may crack and cause loss of sterility.

    Action

    Stryker Endoscopy initiated the recall on 02/07/2008 by notifying its consignees via telephone, as well as sending out Urgent: Device Removal notices. Recipients of affected lots are to inspect their inventory for part/lot numbers and quarantine any affected product. Affected products are to be returned to Stryker Endoscopy and Customer Service should be contacted for replacement alternatives. Also, the "Acknowledgment of recipt" card needs to be signed and returned to Stryker Endoscopy.

    Distribution

    Product was distributed to 8 consignees in CA, OH, PA, CO, MA, and NJ.

    Quantity

    53 units