Device recall
Z-0512-2009: Stryker Custom Cranial Implant Kit, extra large. Distributed by Stryker…
FDA device recall · Class I · Stryker Craniomaxillofacial Division
Key facts
| Recall number (Z-number) | Z-0512-2009 |
|---|---|
| Recall event | 50172 |
| Product | Stryker Custom Cranial Implant Kit, extra large. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00104. Custom cranial implant designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial or craniofacial bone. |
| Product code | KKY |
| Recalling firm | Stryker Craniomaxillofacial Division |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Dec 31, 2009 |
| 510(k) numbers | K043250 |
| FEI number | 3005101424 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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