Device recall
Z-1911-2012: ULTIMA*LX STM,POL 10/12TAP/1M Packaging: The product was packaged within inner…
FDA device recall · Class II · DePuy Orthopaedics, Inc.
Key facts
| Recall number (Z-number) | Z-1911-2012 |
|---|---|
| Recall event | 61749 |
| Product | ULTIMA*LX STM,POL 10/12TAP/1M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a… |
| Product code | JDI |
| Recalling firm | DePuy Orthopaedics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 5, 2013 |
| 510(k) numbers | K972435 |
| FEI number | 1818910 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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