Recall Z-0657-2020— Medtronic Navigation, Inc.

Name: FDA recall Z-0657-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-30

Class II · Ongoing

Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2019-10-30. It names one FDA 510(k) clearance: K971247. Product: Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943. Reason: 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..

Recalling firm: Medtronic Navigation, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2019-10-30
Firm location: Louisville, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K971247 — SNT DISPOSABLE BIOPSY NEEDLESurgical Navigation Technologies, Inc.·cleared 1997-06-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.