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.
FDA Recall Z-1475-2011 · Posted 2011-03-02
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Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeMQP
Date Initiated2010-10-19
Date Terminated2012-09-19
Product Quantity2,163 pieces
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.
Firm 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.
Root Cause
Employee error
Distribution Pattern
Nationwide Distribution -- AL, AZ, CA, CT, ID, KS, MO, NH, NV, NY, OH, OK, TX & UT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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