FDA Device recall Z-0091-2027
Onkos Surgical Inc
- FDA Device
- Class II
- ongoing
- Published 2026-10-14
On 2026-10-14 the FDA classified a Class II recall of Onkos Surgical Inc by Onkos Surgical, citing personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0091-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-24 |
| Published | 2026-10-14 |
| Last updated | 2026-10-21 05:30 UTC |
| Company | Onkos Surgical |
| Distribution | US |
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.
Identifiers
| code_info | UDI: B278PVACREC04M0-Lot #C26-0371; Case# C26-0371 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-21 05:30 UTC. Current status: ongoing.
Other recalls by Onkos Surgical
- Onkos Surgical Inc
FDA Device · Class II · 2026-10-14 · Onkos Surgical - ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants
FDA Device · Class II · 2025-09-03 · Onkos Surgical - ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants
FDA Device · Class II · 2025-09-03 · Onkos Surgical - ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants
FDA Device · Class II · 2025-09-03 · Onkos Surgical - My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003
FDA Device · Class II · 2025-07-09 · Onkos Surgical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0091-2027%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.