Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 So
Summary
The FDA issued a Class II for Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and by United Orthopedic Corp.. Reason: Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant..
Details
Source
Device Recall
External ID
Z-2898-2026
Action Date
2026-08-12
Status
Ongoing
Category
device
Product Description
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
Lot/Code Info: Lot Code: Product number 9323-5312; UDI-DI 04719886908077; Lot number 25FC64
Quantity Affected: 3
Reason for Recall
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Distribution
US Nationwide distribution in the states of Texas and Michigan.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-19
Company
Kaohsiung
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 156 device recalls issued in the same week, part of 400 device-related FDA actions this month.
United Orthopedic Corp. has 6 FDA actions in our database, including 6 recalls.
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 (United Orthopedic Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does United Orthopedic Corp. have FDA actions?
United Orthopedic Corp. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2898-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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