Device recall
Z-0922-2012: MEDPOR TITAN Cranial Temporal with Template - Right, Catalog Number 81038…
FDA device recall · Class II · Howmedica Osteonics Corp dba Stryker Craniomaxillofacial
Key facts
| Recall number (Z-number) | Z-0922-2012 |
|---|---|
| Recall event | 60964 |
| Product | 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. |
| Product code | FTM |
| Recalling firm | Howmedica Osteonics Corp dba Stryker Craniomaxillofacial |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 21, 2012 |
| 510(k) numbers | K040364 |
| FEI number | 1000131961 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database