Z-1133-2017 Class II Terminated
FDA device recall Z-1133-2017 was initiated by Medtronic Advanced Energy, LLC on December 28, 2016 and is designated Class II. Reason for recall: Product sterility compromised due to breach of sterile barrier The recall status is terminated (terminated May 11, 2017). Affected quantity: 275 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 8, 2017
- Initiation Date
- December 28, 2016
- Termination Date
- May 11, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 275 units
Product Description
Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm 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.
Reason for Recall
Product sterility compromised due to breach of sterile barrier
Distribution Pattern
Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.
Code Information
All lot codes