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U.S. Department of Health and Human Services

Class 2 Device Recall Bone Void Filler

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  Class 2 Device Recall Bone Void Filler see related information
Date Initiated by Firm August 26, 2010
Date Posted November 01, 2010
Recall Status1 Terminated 3 on October 27, 2011
Recall Number Z-0169-2011
Recall Event ID 56858
510(K)Number K053228  
Product Classification Filler, bone void, synthetic peptide - Product Code NOX
Product Bone Void Filler, sterile orthopedic product, 510 (k) #K053228. The product is delivered in a syringe which is packaged in an aluminum-backed polyethylene pouch and is distributed one (1) pouch per box. The product affected by this recall was distributed by the recalling firm under six (6) different names. They are: Form-Putty; SBvFShape; Valeo BP; X-Putty; TheriGraft Putty; and SynFlow.
The product is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and are intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The products are intended for use in defects of the skeletal system (i. e. the extremities, spine and pelvis).
Code Information The products are identified with the following Model Numbers and Trade Names:   FormPutty - Model #50-07-0050 FormPutty - Model #-50-07-0100 SBvFShape - Model #-725-7010 SBvFShape - Model #-725-7025 SBvFShape - Model #-725-7050 SBvF Shape - Model #-725-7100 SynFlow - Model #-05-7100-010 SynFlow - Model #-05-7100-025 SynFlow - Model #-05-7100- 050 SynFlow - Model #-05-7100-100 TheriGraft TCP Putty - Model #107010 TheriGraft TCP Putty - Model #107025  TheriGraft TCP Putty - Model #107050 TheriGraft TCP Putty - Model #107100 Valeo BP - Model #817010 Valeo BP - Model #817025 Valeo BP - Model #817050 Valeo B - Model #817100 X-Putty - Model #TS0005 X-Putty - Model #TS0006  The product are also identified with the following Lot Numbers and Expiration Dates: A09I02XY - Expiration Date: 2011-09; A09I03XY - Expiration Date: 2011-09; A09I04XY - Expiration Date: 2011-09; A09K01XY - Expiration Date: 2011-11; A09L01XY - Expiration Date: 2011-12; A10A01XY, Expiration Date: 2012-01; and A10C04XY - Expiration Date: 2012-03. Please Note: XY denotes a 'letter number' combination that specified the size and packaging sequence for the specific unit(s).   
Recalling Firm/
Manufacturer		 Theken Spine Llc
1800 Triplett Blvd
Akron OH 44306-3311
For Additional Information Contact
330-745-8600 Ext. 240
Manufacturer Reason
for Recall		 The firm's quality control testing determined that a separation was occurring between the flowable carrier and the B-TriCalcium Phosphate within some of the product syringes.
FDA Determined
Cause 2		 Other
Action Theken Spine Llc sent Recall Notification Letters dated August 26, 2010, to all customers. One (1) document, titled an 'Urgent Product Recall Notification' letter was addressed: 'ATTENTION; PRODUCT RECALL COORDINATOR/RISK MANAGER.' The other letter was titled: 'RECALL NOTIFICATION.' The recall letters were accompanied by an attached 'Recall Acknowledgement and Return Form' and were sent out via Federal Express. The letters identified the product, the problem, and the action to be taken by the customer. The letters requested that the customers review their product in inventory and identify any product remaining from the affected lot numbers; part numbers; and/or item names for immediate return of these items to the recalling firm. The letters also asked that the customer complete and return the attached Recall Acknowledgement and Return form according to the instructions provided on the form. In addition, the 'RECALL NOTIFICATION' letter instructed the distributor/customers provide information concerning their sub-account customers to Theken Spine so they could issue a Recall Notification letter to these customers as well. To obtain instructions from the recalling firm concerning product return and issuance of credit, customers were instructed to call (866) 942-8698. For questions regarding this recall call (330) 825-8258.
Quantity in Commerce 2904 units (syringes)
Distribution Nationwide Distribution - including UT, SD, TX, AL, PA, CA, MI, OH, NJ, NH, MD, ID, FL, LA, NM, TN, IA, and OR.
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 = NOX and Original Applicant = THERICS, LLC
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