Device evidence

device-recall:cfres:114448

MCA7-2SB - 2MM Fluted Ball, 7.3CM. 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-0768-2014

Evidence summary

Product code: HBE
Recall status: Terminated
Event initiated: March 29, 2012
Root cause: Labeling Change Control
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0768-2014