Device recall
Z-1622-2009: ConforMIS iUni ( Unicondylar Knee System) Left Medial Implant Kit Product Code…
FDA device recall · Class II · Conformis Inc
Key facts
| Recall number (Z-number) | Z-1622-2009 |
|---|---|
| Recall event | 51903 |
| Product | ConforMIS iUni ( Unicondylar Knee System ) Left Medial Implant Kit Product Code: M57220600010. For cemented use only. System consists of femoral and tibial components. The femoral component is CoCrMo personalized on its sub-chondral and articular surfaces to match patient's anatomy. For use in one… |
| Product code | HSX |
| Recalling firm | Conformis Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 14, 2009 |
| 510(k) numbers | K043570, K063432, K072368 |
| FEI number | 3004153240 |
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