Reported Jul 9, 2025 · Ongoing
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained…
Onkos Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Onkos Surgical, Inc. · 77 E Halsey Rd · Parsippany, NJ · 07054-3714
Is this the product you have?
- My3D Personalized Solutions Humeral Cup
- Model NumberC24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
- Lot codes and dates
- Model NumberC24-0223-0003. UDI-DI #: N/A. Serial #: C24-0223
- Amount recalled
- 1 unit
Where it was sold
- Nationwide
- MD
Why it was recalled
Required inspections were not performed on finished product prior to release and distribution.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Onkos Surgical, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.