Device recall
Z-2222-2012: Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers…
FDA device recall · Class II · Conformis Inc
Key facts
| Recall number (Z-number) | Z-2222-2012 |
|---|---|
| Recall event | 62576 |
| Product | Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Right Knee Product Usage : Usage: The iTotal CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and… |
| Product code | JWH |
| Recalling firm | Conformis Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 27, 2013 |
| 510(k) numbers | K103117 |
| 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