Device recall
Z-0529-2013: DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy…
FDA device recall · Class II · DePuy Mitek, Inc., a Johnson & Johnson Co.
Key facts
| Recall number (Z-number) | Z-0529-2013 |
|---|---|
| Recall event | 63732 |
| Product | DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut through cortical and cancellous bone during Cruciate Ligament Repair/Reconstruction of the knee. |
| Product code | HTO |
| Recalling firm | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 21, 2012 |
| FEI number | 1221934 |
At a glance
- None 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