Lower riskMedical device recall · FDA · Published June 16, 2023
Conformis Hip Screw Recall: 30mm screws labeled as 25mm
Conform: Hip screws labeled 25mm but actually 30mm may cause improper fit. Affected units: Model HAA-030-0625-000101, Lot 1232071. Contact manufacturer for details.
“Conformis Hip Screw Recall: 30mm screws labeled as 25mm.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/57835-conformis-hip-screw-recall-30mm-screws-labeled-as-25mm. Based on FDA recall #Z-2405-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2405-2023%22&limit=1).
Conformis Inc. voluntarily recalled CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO units because 30mm screws were labeled as 25mm screws, the FDA said on June 16, 2023.
How to tell if you have it
Brand: Conformis
Product: CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
Model No.: HAA-030-0625-000101
UDI-DI: M572HAA0300625011
Lot No.: 1232071
Quantity: 25 units
The hazard
The recall involves a labeling error where 30mm screws were incorrectly labeled as 25mm screws, according to the FDA.
Context
GovInfoNow's records show Conformis Inc. has 14 other recalls on record since July 24, 2017. Other recent recalls of similar products include Tornier Perip Screw Recall (Dec. 19, 2025) and APTUS 2.8 TriLock Screw Recall (Jan. 9, 2026).
How to tell if you have this one
Check for the model number HAA-030-0625-000101 and lot number 1232071 on the packaging or product label. The product is sterile and labeled as 'CONFORMIS HIP-SCREW-6.5MM X 25MM'.
Brand
Conformis
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the model number HAA-030-0625-000101 and lot number 1232071 on the packaging or product label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 9 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, FL, GA, KS, MA, NV, NY, TN, & VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Georgia, Kansas, Massachusetts, Nevada, New York, Tennessee, Virginia.
Recall timeline
FDA published this recall 2 months 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-2405-2023 (June 16, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2405-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.