FDAClass IIDecember 2, 2020

iTotal Hip Replacement System recall

iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the…

Why was iTotal Hip Replacement System recalled?

Incorrect hip components were provided in kits.

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 numbers 0469255, 0469255

Product
iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the…
Recalling firm
Conformis, Inc.
Quantity
2
Distribution
US Distribution in CA.
Recall date
December 2, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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