Device evidence

device-recall:cfres:114437

MCA5-1SD - 1MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.

Official recall number

Z-0757-2014

Evidence summary

Product code: HBE
Recall status: Terminated
Event initiated: March 29, 2012
Root cause: Labeling Change Control
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0757-2014