FDAClass IIApril 24, 2024

Identity Imprint PS Tibial Tray recall

Identity Imprint PS Tibial Tray Size 4: Lot 540287

Why was Identity Imprint PS Tibial Tray recalled?

Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.

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 Number: TPS-301-T04S; UDI#: M572TPS301T04S011, Lot number 540287

Product
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Recalling firm
Conformis, Inc.
Quantity
3 units
Distribution
US Nationwide distribution in the states of FL, KS and NH.
Recall date
April 24, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls