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U.S. Department of Health and Human Services

Class 2 Device Recall Malibu Polyaxial Reduction Screw

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  Class 2 Device Recall Malibu Polyaxial Reduction Screw see related information
Date Initiated by Firm March 04, 2009
Date Posted September 03, 2009
Recall Status1 Terminated 3 on April 28, 2011
Recall Number Z-1925-2009
Recall Event ID 52115
510(K)Number K051942  
Product Classification Spinal Interlaminal Fixation Appliance - Product Code KWP
Product Malibu Polyaxial Reduction Screw, 6.5 x 40mm Part Number 13-6540

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.
Code Information Lot Number: A1726A
Recalling Firm/
Manufacturer		 SeaSpine, Inc
2302 La Mirada Dr
Vista CA 92081-7862
For Additional Information Contact
760-727-8399 Ext. 218
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWP and Original Applicant = SEASPINE, INC.
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