Z-0657-2020Class II

Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943

Name: Z-0657-2020 Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
Creator: Medtronic Navigation, Inc.
Published: 2019-10-30
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2019-10-30 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Navigation, Inc. began a recall of Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943 on 2019-10-30. FDA classified it as Class II and gives the reason as "The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0657-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-10-30
Posted: 2019-12-06
Recalling firm: Medtronic Navigation, Inc
Product: Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could result in a delay in surgery.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 10/24/2019, Medtronic sent a "URGENT: MEDICAL DEVICE RECALL" notification to consignees via FedEx. The customer notification letter as consignees to do the following: 1. Identify, segregate, and quarantine affected products within your inventory 2. Complete the Customer Confirmation Form. Return the form to Medtronic via email at [email protected] or via fax at 651-367-7075 within 30 days of receipt. 3. Contact Medtronic at 1-888-826-5603 to receive a return materials authorization (RMA) and schedule replacement product. Return affected products to: 4. Medtronic Product Services, Attention: RMA #, 1480 Arthur Ave Louisville, CO 80027 5. If you have questions E-mail Medtronic at [email protected] or call 1-888-826-5603.
Quantity in commerce: 10,448 disposable biopsy needles
Distribution: US: Alabama, Alaska,Arizona,Arkansas,California,Colorado,Connecticut,Delaware,District of Columbia,Florida,Georga, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine,Maryland,Massachusetts,Michigan,Minnesota,Mississippi,Missouri,Montana,Nebraska,Nevada,New Hampshire,New Jersey,New Mexico,New York,North Carolina,North Dakota,Ohio,Oklahoma,Oregon,Pennsylvania,South Carolina,South Dakota,Tennessee,Texas,Utah,Vermont,Virginia,Washington,West Virginia,Wisconsin,Wyoming, OUS: None: Australia, Austria,Bangladesh,Belgium,Bosnia And Herzegovina,Brazil,Bulgaria,Canada,Canary Islands,China,Colombia,Costa Rica,Croatia,Czech Republic,Denmark,Ecuador,Egypt,Finland,France,Germany,Greece,Hungary,Iceland,India,Indonesia,Ireland,Israel,Italy,Japan,Jordan,Kazakhstan,Kenya,Korea, Republic Of,Latvia,Lebanon,Luxembourg,Malaysia,Martinique,Mexico,Netherlands,New Zealand,Pakistan,Philippines,Poland,Portugal,Puerto Rico,Qatar,Reunion,Romania,Russian Federation,Saudi Arabia,Serbia,Slovakia,Slovenia,South Africa,Spain,Sweden,Switzerland,Thailand,Turkey,United Arab Emirates,United Kingdom
Product codes and lots: Lot Numbers: 66503918A 066513519A 066529218A 066535518A 66503919 066513519C 66531018 066512319A 066513519E 066531018A 066512319C 66529218 66535518

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0657-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0657-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-12-18	2019-12-06
Z-0658-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-12-18	2019-12-06
Z-0659-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-12-18	2019-12-06

Product code HAW

K971247Class IISnt Disposable Biopsy NeedleSurgical Navigation Technologies, Inc. / cleared 1997-06-16

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)