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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:112032

IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand and wrist.

Official recall number

Z-0344-2013

Evidence summary

Product code
HWC
Recall status
Terminated
Event initiated
April 13, 2011
Root cause
Employee error
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0344-2013