Recall Z-0091-2027— Onkos Surgical, Inc.
Class II · Ongoing
Class II FDA medical device recall by Onkos Surgical, Inc., initiated 2026-07-24. It names 2 FDA 510(k) clearances: K223348, K212815. 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..
- Recalling firm
- Onkos Surgical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-07-24
- Firm location
- Parsippany, NJ, United States
510(k) clearances named in this recall
2 on FDA's record- K223348 — My3D® Personalized Pelvic Reconstruction
- K212815 — My3D® Personalized Pelvic Reconstruction
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Reason for recall
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
Data sourced from openFDA. This site is unofficial and independent of the FDA.