Device evidence

device-recall:cfres:139479

Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

Official recall number

Z-2794-2015

Evidence summary

Product code: HWC
Recall status: Terminated
Event initiated: August 11, 2015
Root cause: Labeling False and Misleading
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-2794-2015