Device recall
Z-1204-2014: REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with…
FDA device recall · Class II · DePuy Orthopaedics, Inc.
Key facts
| Recall number (Z-number) | Z-1204-2014 |
|---|---|
| Recall event | 67627 |
| Product | REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and… |
| Product code | KRO |
| Recalling firm | DePuy Orthopaedics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 3, 2015 |
| 510(k) numbers | K896048 |
| FEI number | 1818910 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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