UnratedMedical device recall · FDA · Published October 16, 2018
Conformis iTotal Hip Replacement System Recall: Risk of Bone Damage
Conformis recalls hip replacement system with stage 1/2 reamer instruments that may cause bone damage due to improper fit. Affected units have specific catalog and serial numbers.
The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.
Take action
Contact the company
📍Recalling firmConformis, Inc.600 Technology Park Dr · Billerica, MA 01821-4154
“Conformis iTotal Hip Replacement System Recall: Risk of Bone Damage.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69624-conformis-itotal-hip-replacement-system-recall-risk-of-bone-damage. Based on FDA recall #Z-0731-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0731-2019%22&limit=1).
The FDA announced on 2018-10-16 that Conformis Inc. voluntarily recalled the iTotal Hip Replacement System, Total Hip Replacement System (Catalog Number HAA-050-D001-020101, Serial Number 0424647) due to a Class II hazard. The recall was initiated by the firm and has since been terminated.
How to tell if you have it
Brand: Conformis
Product: iTotal Hip Replacement System, Total Hip Replacement System
Catalog Number: HAA-050-D001-020101
Serial Number: 0424647
Distribution: TN
The hazard
According to the FDA, the stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.
Context
GovInfoNow's records show Conformis Inc. has 14 other recalls on record since 2017-07-24. Other recent recalls of similar products include Conformis Hip System Acetabular Liner Recalled Due to Incorrect Labeling (2025-03-25), Conformis Identity Imprint PS Tibial Tray Size 4 Lot 540287: Packaging Mix-Up Risk (2024-03-11), and Conformis Hip Screw Recall: 30mm screws labeled as 25mm (2023-06-16). Other recent recalls of similar products include Howmedica OMNIFIT Series I Acetabular Insert Recall: Oxidation Risk (2026-07-30), U2 Total Knee System: Risk of Improper Assembly Due to Manufacturing Defect (2026-05-20), and Howmedica DURACON XL Angled Tibial Implants Recall: Risk of Wear Debris and Revision Surgery (2026-07-30).
How to tell if you have this one
Check for catalog number HAA-050-D001-020101 and serial number 0424647 on the hip replacement system packaging or documentation.
Brand
Conformis
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for catalog number HAA-050-D001-020101 and serial number 0424647 on the hip replacement system packaging or documentation.
Where it went and when
Where it was distributed
Distributed in Tennessee.
Listed by the agency
Not listed
FDA distribution: “The products were distributed to the following US states: TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Tennessee.
Recall timeline
FDA terminated this recall 20 months 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-0731-2019 (October 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0731-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.