Device evidence

device-recall:cfres:152250

Intact Disposable Wands (part of the Intact System) 777-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

Official recall number

Z-1128-2017

Evidence summary

Product code: KNW
Recall status: Terminated
Event initiated: December 28, 2016
Root cause: Package design/selection
Source snapshot: d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product: Z-1128-2017