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
FDA class
Class II

Why it was recalled

Hazard

Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.

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Product description

Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.

Affected products

UDI: B278PVACREC04M0-Lot #C26-0371; Case# C26-0371

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