Onkos Surgical Inc. My3D Personalized Pelvic Implant recall (Onkos Surgical, Inc.)
Medical deviceClass IIOngoing
Summary: Onkos Surgical, Inc. is recalling 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.
What is being recalled
Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Why
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of North Carolina, and California. (states named: California, North Carolina)
How to tell if yours is affected
UDI: B278PVACREC04M0-Lot #C26-0371; Case# C26-0371
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0091-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 24, 2026 |
| Reported | October 14, 2026 |
| Company | Onkos Surgical, Inc. |
| Company location | Parsippany, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1 implant |
More recalls from Onkos Surgical, Inc. · all medical device recalls · recalls from July 2026