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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:189607

REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845

Official recall number

Z-0160-2022

Evidence summary

Product code
LPH
Recall status
Terminated
Event initiated
October 01, 2021
Root cause
Mixed-up of materials/components
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0160-2022