ENT PRGM 9734636 ADD FUSION NAV AxiEM
Reported: November 26, 2014 Initiated: April 24, 2014 #Z-1584-2014
Product Description
ENT PRGM 9734636 ADD FUSION NAV AxiEM
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
- Recalling Firm
- Medtronic Navigation, Inc.
- Units Affected
- 26,674 total
- Distribution
- Nationwide Distribution
- Location
- Louisville, CO
Frequently Asked Questions
What product was recalled? ▼
ENT PRGM 9734636 ADD FUSION NAV AxiEM. 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-1584-2014.
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