Device recall
Z-1389-2011: S-ROM Distal Femoral Cutting block Guide SZ MED, REF 216311004, non-sterile…
FDA device recall · Class II · Depuy Orthopaedics, Inc.
Key facts
| Recall number (Z-number) | Z-1389-2011 |
|---|---|
| Recall event | 57245 |
| Product | S-ROM Distal Femoral Cutting block Guide SZ MED, REF 216311004, non-sterile, Depuy International Leeds, England. The product is used to make cuts in the femur to prepare the femur for total knee replacement surgery. |
| Product code | LXH |
| Recalling firm | Depuy Orthopaedics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 3, 2012 |
| FEI number | 1818910 |
At a glance
- None 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