CLASS II ONGOING Device recall · Reported 9 Jul 2025 · FDA Enforcement Report
My3D Personalized Solutions Humeral Cup recalled by Onkos Surgical
Onkos Surgical is recalling My3D Personalized Solutions Humeral Cup, distributed nationwide in the US. The recall was initiated on 20 May 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2042-2025
- FDA event ID
- 97005
- Recalling firm
- Onkos Surgical, Parsippany, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 May 2025
- FDA classified
- 27 Jun 2025
- Reported
- 9 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Processing Deviation
- Device type
- Hip & Knee Implants
Timeline
| 20 May 2025 | Recall initiated by company | |
| 27 Jun 2025 | Classified by FDA | +38 days |
| 9 Jul 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Required inspections were not performed on finished product prior to release and distribution.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
Where it was distributed
US Nationwide distribution in the state of Maryland.
Questions about this recall
Why was it recalled?
Required inspections were not performed on finished product prior to release and distribution.
Which lots are affected?
Model Number: C24-0223-0003. UDI-DI #: N/A. Serial #: C24-0223
Where was it sold?
US Nationwide distribution in the state of Maryland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Onkos Surgical
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | My3D Personalized Pelvic Implant, Porous, Left recalled | Onkos Surgical | Other | Nationwide |
| Device | CLASS II | My3D Personalized Pelvic Implant, Porous, Left recalled | Onkos Surgical | Other | Nationwide |
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Other Hip & Knee Implants recalls
All 3,111| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intellijoint Navigation System: Workstation G2 Configured recalled | Intellijoint Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |