Events

Recall of Device Recall Malibu Polyaxial Screw

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by SeaSpine, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52115
  • Event Risk Class
    Class 2
  • Event Number
    Z-1919-2009
  • Event Initiated Date
    2009-03-04
  • Event Date Posted
    2009-09-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82127
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Spinal Interlaminal Fixation Appliance - Product Code KWP
  • 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.

Device

Device Recall Malibu Polyaxial Screw
  • Model / Serial
    Lot Number: A1749B
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • 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.
  • Product Description
    Malibu Polyaxial Screw, 6.5 x 35mm Part Number 12-6535 || 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.
  • Manufacturer
    SeaSpine, Inc

Manufacturer

SeaSpine, Inc
  • Manufacturer Address
    SeaSpine, Inc, 2302 La Mirada Dr, Vista CA 92081-7862
  • Source
    USFDA