Device recall
Z-0147-2016: ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY…
FDA device recall · Class II · ConforMIS, Inc.
Key facts
| Recall number (Z-number) | Z-0147-2016 |
|---|---|
| Recall event | 72108 |
| Product | ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT Catalog Number:TPS1111111 |
| Product code | JWH |
| Recalling firm | ConforMIS, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 2, 2016 |
| 510(k) numbers | K142161, K142404 |
| FEI number | 3009844603 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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