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Terminated

NavLock Tracker *** Rx Only

FDA Recall Z-1693-2020 · Posted 2020-04-10

Recalling FirmMedtronic Navigation, Inc.
Recall StatusTerminated
Product CodeOLO
Date Initiated2019-08-28
Date Terminated2021-05-05
Product Quantity1 unit

Reason for Recall

Product was incorrectly assembled which could affect navigation accuracy of the device.

Firm Action

On 08/28/2019, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification to its customer informing them of the manufacturing issue (incorrect assembly) and instructed them to: 1. Examine their inventory, and immediately quarantine the affected NavLock" Tracker and to return to the Recalling Firm. 2. To contact the Recalling Firm at 1-888-826-5603 to receive a return material authorization (RMA) and to arrange for return and a no-charge replacement. Once an RMA number is obtained, ship the affected product to Medtronic Product Services, 1480 Arthur Ave, Louisville CO 80027. 3. Follow instructions on the attached Customer Confirmation Form. Sign and date the bottom of the form and then return the form to [email protected] or fax it to Medtronic at 651-367-7075.

Root Cause

Employee error

Distribution Pattern

U.S.: NY No O.U.S.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K182104NavLock Trackers, Robotic Reference FrameMedtronic Navigation · 2018-11-02K171267NavLock TrackersMedtronic Navigation · 2017-07-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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