Conformis iTotal Hip Replacement System Recall: Incorrect Components in Kits

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Recalling firmConformis, Inc.600 Technology Park Dr, N/A · Billerica, MA 01821-4154

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Conformis is recalling hip replacement systems with model number HAA-050-D020-020102 due to incorrect components being included in some kits. This could lead to improper joint replacement surgery if used.

Why it’s dangerous

The recall states that incorrect hip components were provided in some kits. This means the surgical components may not fit properly during hip replacement procedures, potentially causing complications.

Who’s affected

Patients who received the Conformis iTotal Hip Replacement System with model number HAA-050-D020-020102 and serial numbers 0469255 are affected. Surgeons and medical facilities using these components are at highest risk.

How to tell if you have this one

Check for the model number HAA-050-D020-020102 on the hip replacement system packaging. Affected units have serial numbers 0469255.

Brand
Conformis
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Review the model number and serial numbers on the hip replacement system packaging to confirm if it is affected.

✎ GovInfoNow

Questions people ask

What is the model number of the recalled hip replacement system?

The model number is HAA-050-D020-020102.

What serial numbers are affected?

Serial numbers 0469255 are affected.

Why is this recall happening?

Incorrect hip components were provided in some kits, which could lead to improper joint replacement surgery.

Take action

Contact Conformis

We’ve drafted a message you can send Conformis to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0475-2021 — Conformis Conformis

Hello,

I own a Conformis that is covered by recall Z-0475-2021 from Conformis.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0475-2021 (September 21, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0475-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Conformis, Inc. recalls iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip

Recall notice