FDAClass IINovember 26, 2014

Instrument Tracker 9733533xom ENT 1pk recall: Sterility Concern

INSTRUMENT TRACKER 9733533XOM ENT 1PK

Why was Instrument Tracker 9733533xom ENT 1pk 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot No.: 130904C 131203A 131003 131024B 130815 130904C 130510 130815 130708B 130815 130815 130716D 130204C 130418B 121128C 121218B 121218A 121128D 130409C 130409D 130123

Product
INSTRUMENT TRACKER 9733533XOM ENT 1PK
Recalling firm
Medtronic Navigation, Inc.
Quantity
26,674 total
Distribution
Nationwide Distribution
Recall date
November 26, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls