Malibu Polyaxial Screw, 6.5 x 40mm Part Number 12-6540 Malibu Spinal System when used as a Pedicle Screw Spinal System o

FDA device recall Z-1920-2009 · posted 2009-09-03 · Terminated

Recall details

Recalling firm

SeaSpine, Inc

Reason for recall

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 taken

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.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

KWP

Quantity affected

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.

Date initiated

2009-03-04

Date posted

2009-09-03

Date terminated

2011-04-28

Location

Vista, CA

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