My3D Personalized Solutions Humeral Cup lacks required inspections
Onkos Surgical is recalling the My3D Personalized Solutions Humeral Cup, Model C24-0223-0003, because required inspections were not performed on finished product prior to release and distribution.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class II recall. The source states only that required inspections were not performed—no defects, illnesses, or injuries are reported. This qualifies as a manufacturing/process deviation without reported adverse health consequences, placing it in the Moderate category.
Plain-English summary
Onkos Surgical, Inc. is recalling the My3D Personalized Solutions Humeral Cup, Model Number C24-0223-0003, a component of a Custom Constrained Shoulder Arthroplasty Device. The recall was initiated because required inspections were not performed on the finished product prior to release and distribution.
This device was distributed nationwide in the state of Maryland. Patients who received this product should consult with their healthcare provider or surgeon about whether their implant is affected and what steps, if any, should be taken.
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.
- Affected units
- 1
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
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