Device evidence

device-recall:cfres:148049

Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Achillon Suture System is a single use, sterile device used to treat acute Achilles tendon ruptures. The Achillon Suture System is a mini-invasive procedure indicated to teat acute Achilles tendon ruptures: Acute rupture of the Achill tendon(<10 days); Rupture located between 2 and 8 cm above calcaneum; Open or closed ruptures

Official recall number

Z-2743-2016

Evidence summary

Product code: NOV
Recall status: Terminated
Event initiated: June 17, 2016
Root cause: Packaging
Source snapshot: d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product: Z-2743-2016