OVERLOOKED

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Class IIOngoing

Onkos Surgical, Inc. recalls 2 products

Recall date · record updated Oct 14, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Onkos Surgical, Inc.
Reason
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution in the states of North Carolina, and California.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99692…

Products (2)

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

    Codes/lots: UDI: B278PVACREC04M0-Lot# C26-0346; Case# C26-0346,Quantity: 1 implantRecall no. Z-0090-2027Class II

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

    Codes/lots: UDI: B278PVACREC04M0-Lot #C26-0371; Case# C26-0371Quantity: 1 implantRecall no. Z-0091-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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