FDA Medical Device Recalls (openFDA)
Onkos Surgical, Inc.: My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
- Recall number
- Z-2042-2025
- 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
- Status
- Open, Classified
- Initiated
- 2025-05-20
- Posted
- 2025-06-27
- Terminated
- not on file
- Reason
- Required inspections were not performed on finished product prior to release and distribution.
- 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
- 1 unit
- Distribution
- US Nationwide distribution in the state of Maryland.
- Lot, serial or model codes
- Model Number: C24-0223-0003. UDI-DI #: N/A. Serial #: C24-0223
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QHQ
- Firm FEI
- 3013450937
- Firm city
- Parsippany
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28