FDAClass IISeptember 26, 2018

Optetrak Logic CC Stem Extension recall

Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals…

Why was Optetrak Logic CC Stem Extension recalled?

Potentially have non-conforming internal threads.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Catalog #: 02-012-60-2216 Serial Number: 5370045

Product
Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals…
Recalling firm
Exactech, Inc.
Quantity
1
Distribution
US Distribution to Ohio only.
Recall date
September 26, 2018
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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