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Z-0090-2027Class II

Onkos Surgical, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Onkos Surgical, Inc.
Product type
Device
Status
Ongoing
Report date
2026-10-14
Distribution
US Nationwide distribution in the states of North Carolina, and California.
Firm state
NJ
Product quantity
1 implant
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Product description

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

Code / lot info

UDI: B278PVACREC04M0-Lot# C26-0346; Case# C26-0346,

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →