Recall Z-0169-2011 ยท NOX Filler, Bone Void, Synthetic Peptide
Theken Spine Llc
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 p
| Date | Nov 1, 2010 (initiated Aug 26, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053228 | THERIGRAFT TCP PUTTY BONE VOID FILLER Therics, LLC, Jan 31, 2006 |