Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
| Recalling firm | Onkos Surgical, Inc. |
|---|---|
| Reason | Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers. |
| Risk class | Class II (Class II · moderate) |
| Status | Ongoing |
| Report date | Oct 14, 2026 |
| Initiated | Jul 24, 2026 |
| Region | NJ, United States |
| Distribution | US Nationwide distribution in the states of North Carolina, and California. |
| Quantity | 1 implant |
| Code/Lot | UDI: B278PVACREC04M0-Lot# C26-0346; Case# C26-0346, |
| Type | Voluntary: Firm initiated |
| Recall number | Z-0090-2027 |
Official source
U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗You can re-verify each item on the official FDA site using its recall number. (Recall number: Z-0090-2027)
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