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Onkos Surgical, Inc.: Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M

Medical DevicesSource: FDA (device) · Date: 2026-10-14

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Onkos Surgical, Inc.
Product
Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Reason / hazard
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of North Carolina, and California.
Recall initiated
2026-07-24
Code info
UDI: B278PVACREC04M0-Lot# C26-0346; Case# C26-0346,
Product quantity
1 implant
Voluntary mandated
Voluntary: Firm initiated
City
Parsippany
State
NJ
Country
United States
Event id
99692
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