FDA-Device2026-10-14Class IIMISBRANDING
Onkos Surgical My3D pelvic implant recalled for wrong-patient distribution mix-up
What this means
One personalized pelvic implant was shipped to the wrong customer due to a distribution error. The device is designed specifically for individual patients and should not be used by anyone other than the intended recipient.
- Contact Onkos Surgical immediately if you received a My3D Personalized Pelvic Implant and confirm it was intended for you.
- Do not use the implant if you are not certain it was prescribed for you.
- Check your implant's UDI or lot number (C26-0346) and case number (C26-0346) against your paperwork.
The agency's original wording
Hazard
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of North Carolina, and California.
Affected count
1 implant
Manufactured in
77 E Halsey Rd, N/A, Parsippany, NJ, United States
Products
Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0090-2027More Onkos Surgical recalls
- FDA-Device2026-10-14Onkos Surgical My3D personalized pelvic implant distributed to wrong patient
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