Implant Recall: Onkos Surgical My3D Pelvic Left REF PV-ACREC-04M
Announced 2026-10-14 · FDA
The recall involves one Onkos Surgical My3D Personalized Pelvic Implant, Porous, Left (REF PV-ACREC-04M). The implants were inadvertently mixed up and distributed to incorrect customers. The affected device was distributed in the United States, including North Carolina and California.
| Brand | Onkos Surgical, Inc. |
|---|---|
| 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. |
| Severity | moderate |
| Units affected | 1 |
| Distribution | US Nationwide distribution in the states of North Carolina, and California. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Consult your surgeon to confirm whether you were implanted with this device and obtain guidance.
- If confirmed, follow your healthcare provider's instructions regarding monitoring, replacement, or any recommended actions.
- Report any adverse symptoms to your healthcare provider and to the manufacturer or FDA recall process as part of the recall.
How to identify the recalled item
| Lot / date codes | UDI: B278PVACREC04M0-Lot# C26-0346; Case# C26-0346, |
|---|---|
| Lot / date codes | UDI: B278PVACREC04M0-Lot #C26-0371; Case# C26-0371 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other implant recalls
- Implant Recall: Arrowhead DE Arrow-LOK · 2026-08-26
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.