FDA-Device2026-10-14Class IIMISBRANDING
Onkos Surgical My3D personalized pelvic implant distributed to wrong patient
What this means
Onkos Surgical distributed one personalized pelvic implant to the wrong customer. The implant was intended for a different patient. The mix-up affected distribution in North Carolina and California.
- If you received a My3D personalized pelvic implant (Ref PV-ACREC-04M, Lot C26-0371), contact Onkos Surgical immediately to verify it was intended for you.
- Do not use the implant until you confirm it matches your prescription and intended procedure.
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-0091-2027More Onkos Surgical recalls
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