MEDPOR TITAN Cranial Temporal with Template - Right, Catalog Number 81038. MEDPOR Biomaterial with embedded Titanium Mes
FDA device recall Z-0922-2012 · posted 2012-01-27 · Terminated
Recall details
- Recalling firm
- Howmedica Osteonics Corp dba Stryker Craniomaxillofacial
- Reason for recall
- 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.
- Action taken
- "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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- FTM
- Quantity affected
- 10 units
- Distribution
- Worldwide Distribution - USA, the state of Michigan, and the countries of Australia and Canada.
- Date initiated
- 2011-12-16
- Date posted
- 2012-01-27
- Date terminated
- 2012-06-21
- Location
- Newnan, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH (K040364) | Porex Surgical, Inc. | 2004-06-30 |