Recall Z-2375-2008 ยท MQV Filler, Bone Void, Calcium Compound
Theken Spine LLC
FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then placed in a box following sterilization. Part # 50-07-0100 Is a flowable resorbable porous bone void filler composed of beta tricalcium phosphate and other calcium phosphates.
| Date | Sep 18, 2008 (initiated Jul 11, 2008) |
| Status | Terminated |
| Reason | The patient label inside the package has an expiration date of 2008-06 when the actual expiration date is 2010-06. |
| Root cause | Labeling mix-ups |
| Action | In a letter dated July 11, 2008, the firm asked their customers to check their inventory for the suspect product. If found they are to return the product for credit or replacement. The firms asks customers to contact them if any units were used for surgery and they will send the correct patient labels. If additional information is needed, customers are to contact Theken Spine Regulatory Affairs or the Quality Department. |
| Quantity | 33 syringes |
| Distribution | Nationwide Distribution --- including states of FL, OH, TX, and UT. |
| 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 |