# Class II recall Z-0090-2027: Onkos Surgical, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0090-2027 |
| Recalling firm | Onkos Surgical, Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left  REF PV-ACREC-04M |
| Reason | Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers. |
| Quantity | 1 implant |
| Distribution | US Nationwide distribution in the states of North Carolina, and California. |
| Recall initiated | 2026-07-24 |
| Reported | 2026-10-14 |
| Firm location | Parsippany, NJ, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 22 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0090-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.