FDAClass IIAugust 31, 2016

Tibial Tray recall

TIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee replacement

Why was Tibial Tray recalled?

The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.

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?

P236112, P239165

Product
TIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee replacement
Recalling firm
Medtronic Sofamor Danek USA Inc
Quantity
3 units
Distribution
AR, MN,MA
Recall date
August 31, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls