TruFit CB Plug Size Code Red, 7mm; quantity 1; Part #605-001-03; product labeled as sterile; manufactured by OsteoBiolog
FDA device recall Z-0440-2007 · posted 2006-12-30 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Reason for recall
- Mis-packaging-product in the package may be a different size than indicated on the labeling.
- Action taken
- Firm notified customers of recall by letter sent via FedEx on 09/29/06.
- Root cause
- Other
- Status
- Terminated
- Product code
- MQV
- Quantity affected
- 32
- Distribution
- Nationwide-Product distributed to distributors, sales reps and hospitals in AL, CA, FL, IL, NJ, NM, NY, PA, TX and UT.
- Date initiated
- 2006-09-29
- Date posted
- 2006-12-30
- Date terminated
- 2007-08-09
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POLYGRAFT BGS; BONE GRAFT SUBSTITUTE (K040047) | Osteobiologics, Inc. | 2004-12-17 |