Device recall
Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
- Recall number
- Z-0090-2027
- Event id
- 99692
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Onkos Surgical, Inc.
- Report date
- Oct 14, 2026
- Posted
- Oct 6, 2026
- Initiated
- Jul 24, 2026
- Center classification date
- Oct 6, 2026
- Product code
- LPH
- Device type
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Reason
- Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
- Root cause
- Labeling mix-ups
- Quantity
- 1 implant
- Code info
- UDI: B278PVACREC04M0-Lot# C26-0346; Case# C26-0346,
- Distribution
- US Nationwide distribution in the states of North Carolina, and California.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Parsippany, NJ, United States