Surgical Humeral Cup Components Recalled for Missing Quality Inspections
Onkos Surgical is recalling My3D Personalized Solutions Humeral Cup components used in shoulder replacement surgery because required quality inspections were not performed before release. No injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for manufacturing quality control failure. The missing required inspections create potential risk that undetected defects could have passed through finished product. No illnesses or injuries reported, but manufacturing control failure on surgical implant warrants high severity.
Plain-English summary
Onkos Surgical, Inc. is recalling the My3D Personalized Solutions Humeral Cup (Model Number C24-0223-0003), a component of custom constrained shoulder arthroplasty devices.
The recall was initiated because required quality inspections were not performed on finished product prior to release and distribution to customers.
The affected product was distributed in Maryland. Patients who received shoulder replacement surgery using this component, or their healthcare providers, should contact Onkos Surgical, Inc. for guidance on next steps.
No illnesses or injuries have been reported. Consumers and healthcare providers with questions should contact the manufacturer immediately.
The recalled product
- Product
- My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
- Manufacturer
- Onkos Surgical, Inc.
- Hazard
- manufacturing-control-failure
- quality-inspection-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: C24-0223-0003. UDI-DI #: N/A. Serial #: C24-0223
Distribution
Distributed nationwide across the United States.
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