FDAClass IINovember 26, 2014

Mouse 9732721 Sterile O-arm 10pk recall: Sterility Concern

MOUSE 9732721 STERILE O-ARM 10PK

Why was Mouse 9732721 Sterile O-arm 10pk 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.: 5051140611 5336060213 5162060112 4734921009

Product
MOUSE 9732721 STERILE O-ARM 10PK
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)
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