Medtronic Advanced Energy, LLC: Medical Device Recall in 2017 - (Recall #: Z-1131-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm 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.

Product Classification:

Class II

Date Initiated: December 28, 2016

Date Posted: February 8, 2017

Recall Number: Z-1131-2017

Event ID: 76130

Reason for Recall:

Product sterility compromised due to breach of sterile barrier

Status: Terminated

Product Quantity: 320 units

Code Information:

All lot codes

Distribution Pattern:

Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated