Recall Z-1923-2009 ยท KWP Appliance, Fixation, Spinal Interlaminal
SeaSpine, Inc
Malibu Polyaxial Screw, 7.5 x 35mm Part Number 12-7535 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.
| Date | Sep 3, 2009 (initiated Mar 4, 2009) |
| Status | Terminated |
| 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. |
| Root cause | Mixed-up of materials/components |
| 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 |
| Quantity | 1,116 Screws in total |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051942 | MALIBU SPINAL SYSTEM Seaspine, Inc., Jul 27, 2005 |