Recall Z-1128-2017 ยท KNW Instrument, Biopsy
Medtronic Advanced Energy, LLC
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.
| Date | Feb 2, 2017 (initiated Dec 28, 2016) |
| Status | Terminated |
| Reason | Product sterility compromised due to breach of sterile barrier |
| Root cause | Package design/selection |
| Action | Medtronic Advanced Energy notified customers by letter on December 27, 2016 via Next Day FEDEX. The communication advises users to immediately stop using the affected Intact Disposable Wands and to quarantine them until they can be returned to Medtronic. Medtronic Sales representatives will arrange for the return of all recalled product. |
| Quantity | 180 units |
| Distribution | Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003190 | EN BLOC BIOPSY SYSTEM Neothermia Corp., Jun 11, 2001 |