FDA-Device2014-11-26Class II

MOUSE 9732721 STERILE O-ARM 10PK

Medtronic Navigation, Inc.
Hazard

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.

Sold states
Nationwide Distribution
Affected count
26,674 total
Manufactured in
826 Coal Creek Cir, N/A, Louisville, CO, United States
Products
MOUSE 9732721 STERILE O-ARM 10PK

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1588-2014

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