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U.S. Department of Health and Human Services

Class 2 Device Recall Endoskeleton Locking Bone Screw Assembly

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  Class 2 Device Recall Endoskeleton Locking Bone Screw Assembly see related information
Date Initiated by Firm July 20, 2015
Date Posted August 03, 2015
Recall Status1 Terminated 3 on October 20, 2015
Recall Number Z-2327-2015
Recall Event ID 71740
510(K)Number K142940  
Product Classification Intervertebral fusion device with integrated fixation, cervical - Product Code OVE
Product Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locking Screws;
5302-3516 / 03.5 x 16mm Locking Screws;
502-3518 / 03.5 x 18mm Locking Screws;
5302-3814 / 03.8 x 14mm Locking Screws;
5302-3816 / 03.8 x 16 mm Locking Screws;
5302-3818 / 03.8 x 18mm Locking Screws.
Code Information Lot numbers: V03, V05, V06
Recalling Firm/
Manufacturer		 TITAN SPINE, LLC
6140 W Executive Dr
Suite A
Mequon WI 53092-4499
For Additional Information Contact Jane Rodd
262-242-7801
Manufacturer Reason
for Recall		 Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Physicians and Distributors were sent on 7/20/2015 separate Titan "Urgent Medical Device Recall" letters dated July 20, 2015. The letters described the problem and the product involved in the recall. Advised consignees to complete and return the enclosed response form. For questions they contact Jane Rodd Senior AQ/RA Manager at 262-242-7801. Distributors were advised to examine their inventory and quarantine the product. If they have further distributed the product they should identify their customers and advise Titan Spine of their contact information.
Quantity in Commerce 137 units
Distribution Distributed in the states of CA, TX, OK, MA, NY, IN, OR, and GA.
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 = OVE and Original Applicant = TITAN SPINE, LLC
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