BEUDAMED
    FDA Recall Terminated

    Malibu Polyaxial Reduction Screw, 6.5 x 50mm Part Number 13-6550 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

    Recall: Z-1927-2009 · Initiated March 4, 2009

    Recall

    Recall Number
    Z-1927-2009
    Event Number
    52115
    Firm
    SeaSpine, Inc
    FEI Number
    3003790069
    Product Code
    KWP
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    March 4, 2009
    Posted
    September 3, 2009
    Terminated
    April 28, 2011
    Address
    2302 La Mirada Dr, Vista, CA, 92081-7862

    Description

    Malibu Polyaxial Reduction Screw, 6.5 x 50mm Part Number 13-6550 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

    Reason

    SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws.

    Action

    In an Urgent Voluntary Product Recall Notification letter dated March 5th, 2009, SeaSpine informed consignees about the reason for recall and asked them to immediately check the products in their possession and hospital inventories to determine if they have any of the affected product. Alternatively, there were told if they would prefer to return to SeaSpine all Malibu Screw inventory that is in their possession, SeaSpine will sort out the affected product upon receipt and will replace their inventory with Malibu Screws that conform to all SeaSpine specifications. The part number and lot are laser marked on the outside of the seat assembly of each screw. SeaSpine asked their consignees to return affected product to them immediately. Attached was a verification form, that they were told to complete and return even if they did not have any product to return. Furthermore their local Sales Manager could assist them in completing the form. They were also encouraged to contact their Sales Manager or Steve Rybka at (760) 727-8399 x202 if they had any questions regarding the recall, any of their products, or would like assistance with the recall.

    Distribution

    Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and WI and country of Greece.

    Quantity

    1,116 Screws in total