Date Initiated by Firm |
October 19, 2012 |
Date Posted |
December 17, 2012 |
Recall Status1 |
Terminated 3 on January 14, 2013 |
Recall Number |
Z-0535-2013 |
Recall Event ID |
63549 |
510(K)Number |
K032812
|
Product Classification |
Spinal vertebral body replacement device - Product Code MQP
|
Product |
Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant VBR 2107-0218 18mm Large Endoskeleton Implant VBR 2107-0220 20mm Large Endoskeleton Implant VBR
Endoskeleton TA VBR is intended for use in the thoracolumbar spine (T1-L5) to replace all or part of a collapsed, damaged, or unstable vertebral body due to tumor or trauma. |
Code Information |
Model # / Lot # 2107-0118: A110822, A120907. 2107-0120 : A110812, A110830, A120263, A120909. 2107-0218: A110813. 2107-0220: A110828, A120262, A120305, A120801, A120901. |
Recalling Firm/ Manufacturer |
TITAN SPINE, LLC 6140 W Executive Dr Suite A Mequon WI 53092-4499
|
For Additional Information Contact |
262-242-7801
|
Manufacturer Reason for Recall |
Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use.
|
FDA Determined Cause 2 |
Labeling False and Misleading |
Action |
Titan sent an Urgent Medical Device Recall letter dated October 19, 2012, to all affected customers. The letter described the problem , the product affected and the corrective measures to be taken. Customers were instructed to review any surgeries that were performed at the L5-51 level with the affected device. Customers were asked to communicate any complications associated with those cases to Titan Spine. Customers with questions should call 1-262-242-7801.
For questions regarding this recall call 262-242-7801. |
Quantity in Commerce |
92 pcs. |
Distribution |
Nationwide Distribution including NV |
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.
|
510(K) Database |
510(K)s with Product Code = MQP and Original Applicant = ORTHOVITA, INC.
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