Onkos Surgical My3D Personalized Pelvic Implant
My3D Personalized Pelvic Implants were inadvertently mixed up and distributed to incorrect customers.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Onkos Surgical, Inc. recalled one My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M because it was inadvertently mixed up and distributed to an incorrect customer. The recall began July 24, 2026, and was added to the FDA's Enforcement Report on October 6, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-Acrec-04M
- UDI-DI
- B278PVACREC04M0
- Lot
- C26-0371
Details
- Company began the recall
- Event ID
- 99692
- Company
- Onkos Surgical, Inc.
- Hazard
- Device defect
- Quantity recalled
- 1 implant
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
