Device evidence

device-recall:cfres:131727

Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.

Official recall number

Z-0581-2015

Evidence summary

Product code: JWH
Recall status: Terminated
Event initiated: November 19, 2014
Root cause: Labeling mix-ups
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0581-2015