Bone Void Filler, sterile orthopedic product, 510 (k) #K053228. The product is delivered in a syringe which is packaged
FDA device recall Z-0169-2011 · posted 2010-11-01 · Terminated
Recall details
- Recalling firm
- Theken Spine Llc
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- NOX
- Quantity affected
- 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.
- Date initiated
- 2010-08-26
- Date posted
- 2010-11-01
- Date terminated
- 2011-10-27
- Location
- Akron, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THERIGRAFT TCP PUTTY BONE VOID FILLER (K053228) | Therics, LLC | 2006-01-31 |