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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:146251

BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

Official recall number

Z-1963-2016

Evidence summary

Product code
PLF
Recall status
Terminated
Event initiated
April 22, 2016
Root cause
Material/Component Contamination
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1963-2016

Field note

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