Device recall
Z-2414-2012: S-Rom Total Hip System Poly Liner Packaging: The insert is placed into an inner…
FDA device recall · Class II · DePuy Orthopaedics, Inc.
Key facts
| Recall number (Z-number) | Z-2414-2012 |
|---|---|
| Recall event | 62765 |
| Product | S-Rom Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch and sealed; the foil pouch and Tyvek/PET pouch are placed into a nylon outer pouch and sealed. This is then placed into a folding carton, labeled, and… |
| Product code | KWZ |
| Recalling firm | DePuy Orthopaedics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 9, 2013 |
| 510(k) numbers | K071117 |
| FEI number | 1818910 |
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