Device evidence

device-recall:cfres:162770

PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.

Official recall number

Z-1625-2018

Evidence summary

Product code: PWI
Recall status: Terminated
Event initiated: February 12, 2018
Root cause: Device Design
Source snapshot: d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product: Z-1625-2018