Osteopore PCL Scaffold Bone Filler: Osteopore Osteoplug-C, Osteoplug, and Osteomesh.
FDA device recall Z-0446-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- OSTEOPORE INTERNATIONAL PTE LTD
- Reason for recall
- Product sterility may be compromised.
- Action taken
- Osteopore sent an Urgent Voluntary Product Recall notice to their consignees by letter dated April 27, 2011.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GXP
- Quantity affected
- 330
- Distribution
- Nationwide distribution - one distributor in TX.
- Date initiated
- 2011-04-27
- Date posted
- 2012-01-11
- Date terminated
- 2012-06-06
- Location
- SINGAPORE, SINGAPORE
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OSTEOPORE PCL SCAFFOLD (K051093) | Osteopore, Inc. | 2006-03-17 |