FDA Device recall Z-0672-2020
iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for…
- FDA Device
- Class II
- terminated
- Published 2019-12-18
On 2019-12-18 the FDA classified a Class II recall of iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for… by Conformis, citing medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0672-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-25 |
| Published | 2019-12-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Conformis |
| Distribution | US |
Product
iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - 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 use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
Reason
Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
Identifiers
| code_info | Serial Number: 0450585 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0672-2020%22
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