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U.S. Department of Health and Human Services

Class 2 Device Recall SpineNet Anterior Cervical Cage

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 Class 2 Device Recall SpineNet Anterior Cervical Cagesee related information
Date Initiated by FirmFebruary 05, 2013
Date PostedAugust 27, 2013
Recall Status1 Terminated 3 on May 02, 2014
Recall NumberZ-2103-2013
Recall Event ID 65917
510(K)NumberK110733 
Product Classification Intervertebral fusion device with bone graft, cervical - Product Code ODP
ProductSpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usage: Is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level
Code Information Ref. No. CL1012-05 Size 10mm x 12mm x 5mm, Ref. No. CL1012-06 Size 10mm x 12mm x 6mm, Ref. No. CL1012-07 Size 10mm x 12mm x 7mm, Ref. No. CL1012-08 Size 10mm x 12mm x 8mm, Ref. No. CL1012-09 Size 10mm x 12mm x 9mm, Ref. No. CL1012-10 Size 10mm x 12mm x 10mm, Ref. No. CL1014-05 Size 12mm x 14mm x 5mm, Ref. No. CL1014-06 Size 12mm x 14mm x 6mm, Ref. No. CL1014-07 Size 12mm x 14mm x 7mm, Ref. No. CL1014-08 Size 12mm x 14mm x 8mm, Ref. No. CL1014-09 Size 12mm x 14mm x 9mm, and Ref. No. CL1014-10 Size 12mm x 14mm x 10mm.    
FEI Number 3006755626
Recalling Firm/
Manufacturer		 SpineNet
1300 Minnesota Ave
Suite 200
Winter Park FL 32789-4800
For Additional Information ContactBrenda Cabrera
407-539-2483
Manufacturer Reason
for Recall		The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to initial product marketing.
FDA Determined
Cause 2		Error in labeling
ActionSpineNET sent a Customer Notification letter dated 02/05/2013 to their only customer (Halifax Medical Center). The letter identified the affected product, problem and actions to be taken. Customers were informed to remove any copies of the original IFU-ACC-01 form from their records and replace with the IFU-ACC-02 form attached to the letter. For questions contact SpineNET office directly.
Quantity in Commerce400
DistributionUSA Nationwide Distribution in the state of Florida
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = ODP
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