Device recall
Z-0991-2017: ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The…
FDA device recall · Class II · ConforMIS, Inc.
Key facts
| Recall number (Z-number) | Z-0991-2017 |
|---|---|
| Recall event | 75969 |
| Product | ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only… |
| Product code | JWH |
| Recalling firm | ConforMIS, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 11, 2017 |
| 510(k) numbers | K161668 |
| FEI number | 3009844603 |
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