Onkos Surgical My3D Humeral Cup Recall: Missing Inspections Risk Injury
Onkos Surgical recalls My3D Humeral Cup model C24-0223-0003 due to missing required inspections before release, potentially causing injury. Affected users should contact the company for details.
Recall notice
Required inspections were not performed on finished product prior to release and distribution.
Contact the company
What happened, in plain English
Onkos Surgical is recalling a specific humeral cup used in shoulder surgery because it wasn't properly inspected before being sold. This could lead to injury if the cup is used in a surgical procedure without proper quality checks. Read more at govinfonow.com/recall/52254-onkos-surgical-my3d-humeral-cup-recall-missing-inspections-risk-injury.
Source Summary by GovInfoNow · govinfonow.com/recall/52254-onkos-surgical-my3d-humeral-cup-recall-missing-inspections-risk-injury · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2042-2025
Cite this page
“Onkos Surgical My3D Humeral Cup Recall: Missing Inspections Risk Injury.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52254-onkos-surgical-my3d-humeral-cup-recall-missing-inspections-risk-injury. Based on FDA recall #Z-2042-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2042-2025%22&limit=1).
Why it’s dangerous
The humeral cup was released without completing required quality inspections. This means it might not meet safety standards, which could cause injury during surgery if the cup fails or doesn't function properly.
Who’s affected
Patients who received this humeral cup as part of a custom shoulder surgery implant are likely affected. Surgeons and medical facilities using this component for procedures are at higher risk.
How to tell if you have this one
Check for the model number C24-0223-0003 on the humeral cup. This is part of a custom shoulder surgery implant system sold by Onkos Surgical.
- Brand
Onkos Surgical- Category
Medical device
What to do — step by step
Contact Manufacturer
Reach out to Onkos Surgical directly to confirm if your humeral cup is affected and get instructions.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution in the state of Maryland.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 50 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-2042-2025 (May 20, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2042-2025 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.