Device recall
Z-1628-2020: iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS…
FDA device recall · Class II · Conformis, Inc.
Key facts
| Recall number (Z-number) | Z-1628-2020 |
|---|---|
| Recall event | 85108 |
| Product | iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The iTotal CR 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… |
| Product code | JWH |
| Recalling firm | Conformis, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 2, 2020 |
| 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