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Navlock Tracker
- Starting date:
- May 17, 2017
- Posting date:
- June 12, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-63592
Reason
Medtronic has become aware of complaints related to third-party (non-Medtronic) navigated instruments used in conjunction with Medtronic Navlock tracker instrumentation. The Navlock trackers are performing as designed. Third-party navigation instruments are being used without collaboration or agreement from Medtronic, the firms designing and marketing these devices may or may not have obtained the required clearance. Medtronic has not validated any third party instrument for use with Navlock trackers. Instruments manufactured by a non-Medtronic manufacturer have not been evaluated by Medtronic for compatibility with the Navlock.
Affected products
Navlock Tracker
Lot or serial number
Serial numbers:
- 9734489
- 9734590
- 9734682
- 9734683
- 9734833
- 9734906
- 9734908
- 9734914
Model or catalog number
Not Applicable
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES