⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

United Orthopedic Corp.: Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A

Medical DevicesSource: FDA (device) · Date: 2026-08-12

Read the official notice at FDA (device) →

Share on XFacebookRedditEmail

Get alerts for United Orthopedic

Guides: Which agency handles which recall (FDA vs USDA vs CPSC vs NHTSA)

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
United Orthopedic Corp.
Product
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
Reason / hazard
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of Texas and Michigan.
Recall initiated
2026-03-19
Code info
Lot Code: Product number 9323-5312; UDI-DI 04719886908077; Lot number 25FC64
Product quantity
3
Voluntary mandated
Voluntary: Firm initiated
City
Kaohsiung
Country
Taiwan
Event id
99025
Free daily digest + "My products" watchlist

Get the daily digest, and tell us what to watch. Everything is optional except your email.

Free allergen alerts:

Categories:

Privacy: we store only what you enter here, use it only to send recall alerts you asked for, never sell or share it, and you can unsubscribe anytime. Double opt-in: we will email you a confirmation link before sending anything; alerts start only after you confirm. Every email has unsubscribe and manage-watchlist links.