UnratedMedical device recall · FDA · Published September 21, 2020
Conformis iTotal Hip Replacement System Recall: Incorrect Components in Kits
Conformis recalls iTotal Hip Replacement System model HAA-050-D02: Incorrect hip components in kits may lead to improper joint replacement. Affected units have serial numbers 0469255.
“Conformis iTotal Hip Replacement System Recall: Incorrect Components in Kits.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64246-conformis-itotal-hip-replacement-system-recall-incorrect-components-in-kits. Based on FDA recall #Z-0475-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0475-2021%22&limit=1).
Conformis Inc. voluntarily recalled the iTotal Hip Replacement System, model HAA-050-D020-020102, because incorrect hip components were provided in kits, according to the FDA on September 21, 2020.
How to tell if you have it
Brand: Conformis
Product: iTotal Hip Replacement System
Model number: HAA-050-D020-020102
Serial numbers: 0469255, 0469255
Quantity: 2 units
Distribution: California
The hazard
The recall involves the Conformis Hip System, which includes standard hip replacement components as well as patient-specific femoral stems and single-use instrumentation. The hazard is that incorrect hip components were provided in the kits.
Context
GovInfoNow's records show Conformis Inc. has 14 other recalls on record since July 24, 2017. Other recent recalls of similar products include Conformis Hip System Acetabular Liner Recalled Due to Incorrect Labeling (March 25, 2025), Conformis Identity Imprint PS Tibial Tray Size 4 Lot 540287: Packaging Mix-Up Risk (March 11, 2024), and Conformis Hip Screw Recall: 30mm screws labeled as 25mm (June 16, 2023). Other recent recalls of similar products include U2 Total Knee System Femoral Valgus Adaptor Recall (May 20, 2026), U2 Total Knee System PSA Box Trial: Incomplete Screw Assembly Risk (May 20, 2026), and Smith & Nephew BIOSURE HA Screw Recall: Labeling Error Risk (November 24, 2025).
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.
Where it went and when
Where it was distributed
Distributed in California.
Listed by the agency
Not listed
FDA distribution: “US Distribution in CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.