PlainRecalls
FDA Devices Moderate Class II Terminated

INSTRUMENT TRACKER 9733533XOM ENT 1PK

Reported: November 26, 2014 Initiated: April 24, 2014 #Z-1586-2014

Product Description

INSTRUMENT TRACKER 9733533XOM ENT 1PK

Reason for Recall

Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.

Details

Units Affected
26,674 total
Distribution
Nationwide Distribution
Location
Louisville, CO

Frequently Asked Questions

What product was recalled?
INSTRUMENT TRACKER 9733533XOM ENT 1PK. Recalled by Medtronic Navigation, Inc.. Units affected: 26,674 total.
Why was this product recalled?
Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 26, 2014. Severity: Moderate. Recall number: Z-1586-2014.