Device recall
Z-2254-2014: Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA…
FDA device recall · Class II · Ortho Development Corporation
Key facts
| Recall number (Z-number) | Z-2254-2014 |
|---|---|
| Recall event | 68898 |
| Product | Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component |
| Product code | JWH |
| Recalling firm | Ortho Development Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 6, 2014 |
| 510(k) numbers | K994370 |
| FEI number | 3017298928 |
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