Recall Z-0443-2007 ยท MQV Filler, Bone Void, Calcium Compound
Smith & Nephew, Inc. Endoscopy Division
TruFit BGS Plug Size Code Blue, 9mm; quantity 1; Part #600-001-05; 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 | 34 |
| 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
This recall record lists no 510(k) number.