Recall Z-0922-2012 ยท FTM Mesh, Surgical
Howmedica Osteonics Corp dba Stryker Craniomaxillofacial
MEDPOR TITAN Cranial Temporal with Template - Right, Catalog Number 81038. MEDPOR Biomaterial with embedded Titanium Mesh Implants are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma.
| Date | Jan 27, 2012 (initiated Dec 16, 2011) |
| Status | Terminated |
| Reason | The template that is packaged with this implant was not packaged according to specification. The template was packaged in a single pouch instead of a double pouch. |
| Root cause | Packaging process control |
| Action | "Urgent Product Recall" Notification letters and Product Accountability Forms have been sent on January 13, 2012 domestically via FedEx and Internationally via DHL. Customers were informed of the product problem and provided risk mitigation information. Return of the Product Accountability/Acknowledgement form was requested. Questions were directed to 770-254-4423. |
| Quantity | 10 units |
| Distribution | Worldwide Distribution - USA, the state of Michigan, and the countries of Australia and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040364 | MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH Porex Surgical, Inc., Jun 30, 2004 |