BEUDAMED
    FDA Recall Terminated

    Disc Space Distractor Label states - Specialty Disc Space Distractor, Mfg by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 Used to assist in spinal fusions. It is to be placed between the vertebral bodies in the specified disc space; the t-handle can then be rotated clockwise expanding the distal paddle assembly to a specified height. Once the determined height has been achieved the t-handle can be rotated counter-clockwise retracting the paddles and then removed from the defect site. instrument is not used to sustain or support life. it is intended to be used as a manual surgical instrument during inter body disk replacement to distract the vertebrae to aid in removal of disc space, cartilage, bone and soft tissue.

    Recall: Z-0895-2011 · Initiated December 7, 2010

    Recall

    Recall Number
    Z-0895-2011
    Event Number
    57462
    Firm
    Stryker Spine
    FEI Number
    3004024955
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 7, 2010
    Posted
    January 12, 2011
    Terminated
    November 14, 2012
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611

    Description

    Disc Space Distractor Label states - Specialty Disc Space Distractor, Mfg by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 Used to assist in spinal fusions. It is to be placed between the vertebral bodies in the specified disc space; the t-handle can then be rotated clockwise expanding the distal paddle assembly to a specified height. Once the determined height has been achieved the t-handle can be rotated counter-clockwise retracting the paddles and then removed from the defect site. instrument is not used to sustain or support life. it is intended to be used as a manual surgical instrument during inter body disk replacement to distract the vertebrae to aid in removal of disc space, cartilage, bone and soft tissue.

    Reason

    Stryker Spine has received reports of the Disc Space Distractors failing during surgical procedures.

    Action

    Stryker Spine sent an URGENT PRODUCT RECALL letter dated December 7, 2010, via Fedex to all affected customers.. The letter identified the product, the problem, and the action they should take. Customers were instructed to examine their inventory and hospital locations to identify the product. Reconcile IBD Disc Space Distractors with the catalog and lot numbers referenced. Complete the Customer Response Form and distribution sheet and fax a copy of the Customer Response Form to Regulatory Compliance at 201-760-8370. Return the affected product using the enclosed pre-paid mailing label to Regulatory Compliance, Stryker Spine 6 Pearl Court Allendale, New Jersey 07401 For questions regarding this recall call 201-760-8206.

    Distribution

    Nationwide Distribution including AZ, FL, MA, NY, PA, and TX

    Quantity

    21 units