Z-1129-2017Class II

Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm Disposable

Name: Z-1129-2017 Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm Disposable
Creator: Medtronic Advanced Energy, LLC
Published: 2016-12-28
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2016-12-28 / Terminated / root cause: packaging

FDA source

Medtronic Advanced Energy, LLC began a recall of Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to... on 2016-12-28. FDA classified it as Class II and gives the reason as "Product sterility compromised due to breach of sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1129-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-28
Posted: 2017-02-02
Terminated: 2017-05-11
Recalling firm: Medtronic Navigation, Inc
Product: Intact Disposable Wands (part of the Intact System) 777-112BT: 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.
Product code: KNW Instrument, Biopsy
Reason for recall: Product sterility compromised due to breach of sterile barrier
Root cause tag: packaging
FDA 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 in commerce: 252 units
Distribution: Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.
Product codes and lots: All lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1129-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1126-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-02-02
Z-1127-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-02-02
Z-1128-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-02-02
Z-1129-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-02-02
Z-1130-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-02-02
Z-1131-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-02-02
Z-1132-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-02-02
Z-1133-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-02-02
Z-1134-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-02-02
Z-1135-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-02-02
Z-1136-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-02-02

Product code KNW

K003190Class IIEn Bloc Biopsy SystemNeothermia Corp. / cleared 2001-06-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)