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U.S. Department of Health and Human Services

Class 2 Device Recall Vu aPOD Intervertebral Body Fusion Device

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  Class 2 Device Recall Vu aPOD Intervertebral Body Fusion Device see related information
Date Initiated by Firm October 19, 2010
Date Posted March 02, 2011
Recall Status1 Terminated 3 on September 19, 2012
Recall Number Z-1475-2011
Recall Event ID 57100
510(K)Number K080822  
Product Classification Spinal Vertebral Body Replacement Device - Product Code MQP
Product Vu a-POD Intervertebral Body Fusion Device. Packaged as surgical kits containing all implants and instruments required for a procedure. Also packaged as individual instruments and implants in poly bags distributed as replenishment for surgical kits. Theken Spine, LLC, Akron, OH 44306.

Indicated for use as an adjunct for fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1.
Code Information Model #'s: 21-11-2708, 21-21-2710, 21-23-3510, 21-40-0110, 21-LT-3508, 21-11-2710, 21-21-2712, 21-23-3512, 21-40-0120, 21-LT-3510, 21-11-2712, 21-21-2714, 21-23-3514, 21-40-0130, 21-LT-3512, 21-11-3108, 21-21-2716, 21-23-3516, 21-40-0131, 21-LT-3514, 21-11-3110, 21-21-3108, 21-23-3908, 21-40-0135, 21-LT-3516, 21-11-3112, 21-21-3110, 21-23-3910, 21-40-0140, 21-LT-3908, 21-11-3114, 21-21-3112, 21-23-3912, 21-40-0150, 21-LT-3910, 21-11-3116, 21-21-3114, 21-23-3914, 21-40-0160, 21-LT-3912, 21-11-3508, 21-21-3116, 21-23-3916, 21-40-0165, 21-LT-3914, 21-11-3510, 21-21-3508, 21-24-2708, 21-40-0170, 21-LT-3916, 21-11-3512, 21-21-3510, 21-24-2710, 21-40-0180, 21-TA-2708, 21-11-3514, 21-21-3512, 21-24-2712, 21-40-0190, 21-TA-2710, 21-11-3516, 21-21-3514, 21-24-2714, 21-40-0190-3, 21-TA-2712, 21-11-3908, 21-21-3516, 21-24-2716, 21-40-0200, 21-TA-2714, 21-11-3910, 21-21-3908, 21-24-3108, 21-40-0215, 21-TA-2716, 21-11-3912, 21-21-3910, 21-24-3110, 21-40-0245, 21-TA-3108, 21-11-3914, 21-21-3912, 21-24-3112, 21-40-0290, 21-TA-3110, 21-11-3916, 21-21-3914, 21-24-3114, 21-40-0400, 21-TA-3112, 21-20-2708, 21-21-3916, 21-24-3116, 21-40-0500, 21-TA-3114, 21-20-2710, 21-22-3112, 21-24-3508, 21-50-0100, 21-TA-3116, 21-20-2712, 21-22-3114, 21-24-3510, 21-50-0110, 21-TA-3508, 21-20-2714, 21-22-3116, 21-24-3512, 21-50-0210, 21-TA-3510, 21-20-2716, 21-22-3512, 21-24-3514, 21-50-0310, 21-TA-3512, 21-20-3108, 21-22-3514, 21-24-3516, 21-50-0410, 21-TA-3514, 21-20-3110, 21-22-3516, 21-24-3908, 21-99-0001, 21-TA-3516, 21-20-3112, 21-22-3912, 21-24-3910, 21-99-0002, 21-TA-3908, 21-20-3114, 21-22-3914, 21-24-3912, 21-99-0002-2-1, 21-TA-3910, 21-20-3116, 21-22-3916, 21-24-3914, 21-99-0002-3-1, 21-TA-3912, 21-20-3508, 21-23-2708, 21-24-3916, 21-99-0002-3-2, 21-TA-3914, 21-20-3510, 21-23-2710, 21-25-3112, 21-LT-2708, 21-TA-3916, 21-20-3512, 21-23-2712, 21-25-3114, 21-LT-2710, 21-XT-3112, 21-20-3514, 21-23-2714, 21-25-3116, 21-LT-2712, 21-XT-3114, 21-20-3516, 21-23-2716, 21-25-3512, 21-LT-2714, 21-XT-3116, 21-20-3908, 21-23-3108, 21-25-3514, 21-LT-2716, 21-XT-3512, 21-20-3910, 21-23-3110, 21-25-3516, 21-LT-3108, 21-XT-3514, 21-20-3912, 21-23-3112, 21-25-3912, 21-LT-3110, 21-XT-3516, 21-20-3914, 21-23-3114, 21-25-3914, 21-LT-3112, 21-XT-3912, 21-20-3916, 21-23-3116, 21-25-3916, 21-LT-3114, 21-XT-3914, 21-21-2708, 21-23-3508, 21-40-0100, 21-LT-3116 & 21-XT-3916.
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact
609-275-0500
Manufacturer Reason
for Recall		 The IFU provided with the device contains incorrect information in the Indications for Use Section, stating the following: The Theken Spine Vu a"POD Intervertebral Body Fusion Device is intended for use as a stand alone implant when used with the SpinPlate provided in the set.
FDA Determined
Cause 2		 Employee error
Action On 10/19/2010 the firm sent "URGENT : FIELD CORRECTION ACTION Letters to their customers. The letters identified the affected product and explained the reason for the recall. The letter also stated that the issue is not believed to have a health impact on patients. Physicians are asked to continue to exercise their clinical judgment with any periodic patient follow up. Attached to the letters were IFUs containing the correct information. Customers are to complete and return the enclosed Recall Acknowledgement Form per the instructions provided. Questions can be directed to Suzanne B. Wojcik, Sr. Dir Regulatory Affairs and Quality Assurance, at 330-835-8528.
Quantity in Commerce 2,163 pieces
Distribution Nationwide Distribution -- AL, AZ, CA, CT, ID, KS, MO, NH, NV, NY, OH, OK, TX & UT.
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 = MQP and Original Applicant = THEKEN SPINE LLC
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