Lower riskMedical device recall · FDA · Published March 25, 2025
Conformis Hip System Acetabular Liner Recalled Due to Incorrect Labeling
Conformis recalls specific acetabular liner models for hip systems due to incorrect labeling. This may lead to improper use. Affected customers should contact Conformis for details.
The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.
Take action
Contact the company
📍Recalling firmConformis Inc.600 Research Dr · Wilmington, MA 01887-4437
“Conformis Hip System Acetabular Liner Recalled Due to Incorrect Labeling.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52534-conformis-hip-system-acetabular-liner-recalled-due-to-incorrect-labeling. Based on FDA recall #Z-1569-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1569-2025%22&limit=1).
Conformis Inc. voluntarily recalled the restor3d Cordera Hip System acetabular liner group with model number HDL-060-C22L-000101 from lot 1788258, according to the FDA on March 25, 2025. The product was distributed nationwide and in California, Florida, Nevada, and Tennessee.
How to tell if you have it
Brand: Conformis
Product: restor3d Cordera Hip System Acetabular Liner Group C 36mm Lip
Model Number: HDL-060-C22L-000101
Lot Code: 1788258
The hazard
The FDA said the hip cup liner contained a hooded liner but was incorrectly labeled as having a standard liner. This packaging discrepancy creates a risk of surgical error.
Context
GovInfoNow's records show Conformis Inc. has had 14 other recalls since July 24, 2017. On March 11, 2024, the company recalled tibial trays due to a packaging mix-up involving swapped lots. Other recent recalls of similar products include Encore Medical EMPOWR Acetabular System Recall (Jan. 5, 2026) and Smith & Nephew BIOSURE HA Screw Recall (Nov. 24, 2025).
How to tell if you have this one
Check for the model number HDL-060-C22L-000101 on the acetabular liner. The lot number 1788258 is associated with this specific incorrect labeling issue.
Brand
Conformis
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Conformis
Reach out to Conformis directly for guidance on whether the liner is affected and next steps.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, FL, NV, TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Nevada, Tennessee.
Recall timeline
FDA published this recall 29 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-1569-2025 (March 25, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1569-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.