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.
Required inspections were not performed on finished product prior to release and distribution.
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.
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.
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.
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.
Reach out to Onkos Surgical directly to confirm if your humeral cup is affected and get instructions.
The recall states that required inspections were not performed, so it may not be safe. Affected users should contact Onkos Surgical for details.
Look for the model number C24-0223-0003 on the humeral cup, which is part of a custom shoulder surgery implant system.
Contact Onkos Surgical directly to determine if your humeral cup is affected and get instructions.
We’ve drafted a message you can send Onkos Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2042-2025 — Onkos Surgical Onkos Surgical Hello, I own a Onkos Surgical that is covered by recall Z-2042-2025 from Onkos Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.