PlainRecalls
FDA Devices Moderate Class II Terminated

SPHERES 8801075 5/TRAY 12PK

Reported: November 26, 2014 Initiated: April 24, 2014 #Z-1596-2014

Product Description

SPHERES 8801075 5/TRAY 12PK

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?
SPHERES 8801075 5/TRAY 12PK. 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-1596-2014.