Device recall
Z-2253-2014: Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a…
FDA device recall · Class II · Ortho Development Corporation
Key facts
| Recall number (Z-number) | Z-2253-2014 |
|---|---|
| Recall event | 68898 |
| Product | Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum |
| Product code | KWY |
| Recalling firm | Ortho Development Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 6, 2014 |
| 510(k) numbers | K050966 |
| FEI number | 3017298928 |
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