FDA Device recall Z-2222-2012
Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Rig…
- FDA Device
- Class II
- terminated
- Published 2012-08-29
On 2012-08-29 the FDA classified a Class II recall of Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Rig… by Conformis, citing addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2222-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-17 |
| Published | 2012-08-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Conformis |
| Distribution | US |
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 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, patello-femoral or bi-compartmental prosthesis.
Reason
Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique
Identifiers
| code_info | All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2222-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.