Device evidence

device-recall:cfres:118930

00595501201 Provisional CR-FLEX FEM PROV SZ B-L, Rx, Sterile; 00595501202 Provisional CR-FLEX FEM PROV SZ B-R, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

Official recall number

Z-2035-2013

Evidence summary

Product code: JWH
Recall status: Terminated
Event initiated: June 07, 2013
Root cause: Labeling design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-2035-2013