Recall Z-0446-2012 ยท GXP Methyl Methacrylate For Cranioplasty
OSTEOPORE INTERNATIONAL PTE LTD
Osteopore PCL Scaffold Bone Filler: Osteopore Osteoplug-C, Osteoplug, and Osteomesh.
| Date | Jan 11, 2012 (initiated Apr 27, 2011) |
| Status | Terminated |
| Reason | Product sterility may be compromised. |
| Root cause | Nonconforming Material/Component |
| Action | Osteopore sent an Urgent Voluntary Product Recall notice to their consignees by letter dated April 27, 2011. |
| Quantity | 330 |
| Distribution | Nationwide distribution - one distributor in TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051093 | OSTEOPORE PCL SCAFFOLD Osteopore, Inc., Mar 17, 2006 |