FDAClass IIApril 20, 2022

iTotal Identity Posterior Stabilised recall

iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101

Why was iTotal Identity Posterior Stabilised recalled?

Incorrect tibial base plate implant packaged in kit

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?

Serial Number: 0496242 UDI: M572TPS3011113011

Product
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Recalling firm
Conformis, Inc.
Quantity
1 unit
Distribution
MS
Recall date
April 20, 2022
Classification
Class II
Status
Completed
Agency
FDA (device)
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