Official recall notice
FDA DeviceClass IINotable
Onkos Surgical Inc. My3D Personalized Pelvic Recall (Oct 2026)
Product: Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
- Recall date
- 2026-10-14
- Brand
- Onkos Surgical, Inc.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
Product description
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
Affected products
UDI: B278PVACREC04M0-Lot# C26-0346; Case# C26-0346,