Device recall
Z-2257-2014: Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage…
FDA device recall · Class II · Ortho Development Corporation
Key facts
| Recall number (Z-number) | Z-2257-2014 |
|---|---|
| Recall event | 68898 |
| Product | Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the femoral component where additional joint constraint is needed |
| Product code | JWH |
| Recalling firm | Ortho Development Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 6, 2014 |
| 510(k) numbers | K060569 |
| 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