Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Summary
The FDA issued a Class II for Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC by Onkos Surgical, Inc.. Reason: Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers..
Details
Source
Device Recall
External ID
Z-0090-2027
Action Date
2026-10-14
Status
Ongoing
Category
device
Product Description
Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Lot/Code Info: UDI: B278PVACREC04M0-Lot# C26-0346; Case# C26-0346,
Quantity Affected: 1 implant
Reason for Recall
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
Distribution
US Nationwide distribution in the states of North Carolina, and California.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-24
Company
Parsippany, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 220 device recalls issued in the same week, part of 502 device-related FDA actions this month.
Onkos Surgical, Inc. has 18 FDA actions in our database, including 15 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Onkos Surgical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Onkos Surgical, Inc. have FDA actions?
Onkos Surgical, Inc. has 18 FDA actions in our database, including 15 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0090-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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