Device evidence

device-recall:cfres:142378

Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on order. Tray set is not sealed. These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. Tray catalog number is: Tray designated as ST0485-037.

Official recall number

Z-0448-2016

Evidence summary

Product code: LRZ
Recall status: Terminated
Event initiated: November 10, 2015
Root cause: Component design/selection
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0448-2016