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U.S. Department of Health and Human Services

Class 2 Device Recall Titan Spine Endoskeleton TA Implant

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 Class 2 Recall
Titan Spine Endoskeleton TA Implant
see related information
Date Posted December 17, 2012
Recall Status1 Terminated on January 14, 2013
Recall Number Z-0535-2013
Recall Event ID 63549
Premarket Notification
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, Wisconsin 53092-4499
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
MISBRANDING: 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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQP and Original Applicant = ORTHOVITA, INC.
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