Onkos Surgical My3D Personalized Pelvic Implant (Z-0090-2027) Recall
Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Onkos Surgical My3D Personalized Pelvic Implant recalled?
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Which lot codes, UPCs or models are affected?
UDI: B278PVACREC04M0-Lot# C26-0346; Case# C26-0346,
- Agency record number
- Z-0090-2027
- Product
- Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
- Recalling firm
- Onkos Surgical, Inc.
- Quantity
- 1 implant
- Distribution
- US Nationwide distribution in the states of North Carolina, and California.
- Recall started
- July 24, 2026
- Report date
- October 14, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)