Device recall
Z-1043-2015: Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended…
FDA device recall · Class II · Stryker Howmedica Osteonics Corp.
Key facts
| Recall number (Z-number) | Z-1043-2015 |
|---|---|
| Recall event | 70100 |
| Product | Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) design that is assembled during surgery. The shell is press-fit into the patients prepared acetabulum… |
| Product code | MEH |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 22, 2016 |
| 510(k) numbers | K983382 |
| FEI number | 3003070421 |
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