My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Sho
Summary
The FDA issued a Class II for My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is by Onkos Surgical, Inc.. Reason: Required inspections were not performed on finished product prior to release and distribution..
Details
Source
Device Recall
External ID
Z-2042-2025
Action Date
2025-07-09
Status
Ongoing
Category
device
Product Description
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
Lot/Code Info: Model Number: C24-0223-0003. UDI-DI #: N/A. Serial #: C24-0223
Quantity Affected: 1 unit
Reason for Recall
Required inspections were not performed on finished product prior to release and distribution.
Distribution
US Nationwide distribution in the state of Maryland.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-20
Company
Parsippany, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 153 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Onkos Surgical, Inc. has 16 FDA actions in our database, including 13 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Onkos Surgical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Onkos Surgical, Inc. have FDA actions?
Onkos Surgical, Inc. has 16 FDA actions in our database, including 13 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2042-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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