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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:162763

Capio Standard Box 4 (Capio PC); Model #M0068312321. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.

Official recall number

Z-1620-2018

Evidence summary

Product code
PWI
Recall status
Terminated
Event initiated
February 12, 2018
Root cause
Device Design
Source snapshot
d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product
Z-1620-2018

Field note

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