Recalls / —
—#180507
Product
NavLock Tracker *** Rx Only
- FDA product code
- OLO — Orthopedic Stereotaxic Instrument
- Device class
- Class 2
- Medical specialty
- Neurology
- 510(k) numbers
- K171267, K182104
- Affected lot / code info
- Product Number: 9736061 UDI (GTIN/UPN): 00763000123185 Serial Number: 000012585
Why it was recalled
Product was incorrectly assembled which could affect navigation accuracy of the device.
Root cause (FDA determination)
Employee error
Action the firm took
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 RS.NavFCA@medtronic.com or fax it to Medtronic at 651-367-7075.
Recalling firm
- Firm
- Medtronic Navigation, Inc.
- Address
- 826 Coal Creek Cir, Louisville, Colorado 80027-9710
Distribution
- Distribution pattern
- U.S.: NY No O.U.S.
Timeline
- Recall initiated
- 2019-08-28
- Posted by FDA
- 2020-04-10
- Terminated
- 2021-05-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #180507. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.