Recall Z-0440-2007 ยท MQV Filler, Bone Void, Calcium Compound
Smith & Nephew, Inc. Endoscopy Division
TruFit CB Plug Size Code Red, 7mm; quantity 1; Part #605-001-03; product labeled as sterile; manufactured by OsteoBiologics, Inc., San Antonio, TX.
| Date | Dec 30, 2006 (initiated Sep 29, 2006) |
| Status | Terminated |
| Reason | Mis-packaging-product in the package may be a different size than indicated on the labeling. |
| Root cause | Other |
| Action | Firm notified customers of recall by letter sent via FedEx on 09/29/06. |
| Quantity | 32 |
| Distribution | Nationwide-Product distributed to distributors, sales reps and hospitals in AL, CA, FL, IL, NJ, NM, NY, PA, TX and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040047 | POLYGRAFT BGS; BONE GRAFT SUBSTITUTE Osteobiologics, Inc., Dec 17, 2004 |