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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = OVE
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