Onkos Surgical, Inc. recalls Onkos Surgical Inc. My3D Personalized Pelvic Implant
- Recalling company
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 24, 2026
- Reported
- Oct 14, 2026
- Distribution
- US Nationwide distribution in the states of North Carolina, and California.
- Status
- Ongoing
- Quantity
- 1 implant
- Lot / codes
- UDI: B278PVACREC04M0-Lot #C26-0371; Case# C26-0371
- Company location
- Parsippany, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0091-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0091-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.