Z-2042-2025Class II

My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom...

Name: Z-2042-2025 My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom...
Creator: Onkos Surgical, Inc.
Published: 2025-05-20
License: https://open.fda.gov/license/

Onkos Surgical, Inc. / initiated 2025-05-20 / Open, Classified / root cause: manufacturing process

FDA source

Onkos Surgical, Inc. began a recall of My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device on 2025-05-20. FDA classified it as Class II and gives the reason as "Required inspections were not performed on finished product prior to release and distribution". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2042-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-20
Posted: 2025-06-27
Recalling firm: Onkos Surgical, Inc.
Product: My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
Product code: QHQ Total Shoulder Arthroplasty System
Reason for recall: Required inspections were not performed on finished product prior to release and distribution.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm notified the single customer via telephone call on 05/20/2025 and it was followed up with a letter emailed on 05/29/2025. The notification instructed the customer to segregate and quarantine the component immediately and return the implant component in question within 2 business days of acknowledgment of notification. The component was returned on 05/22/2025. Distributors have responsibility for maintaining field inventory and are responsible for the inventory, even if located on site at a hospital as the products are not purchased/owned by the hospital or patient prior to implantation.
Quantity in commerce: 1 unit
Distribution: US Nationwide distribution in the state of Maryland.
Product codes and lots: Model Number: C24-0223-0003. UDI-DI #: N/A. Serial #: C24-0223

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2042-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2042-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-09	2025-06-27

Product code QHQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)