CLASS II ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report

U2 Total Knee System Femoral offset bushing recalled

United Orthopedic is recalling U2 Total Knee System Femoral offset bushing, distributed nationwide in the US. The recall was initiated on 19 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: Product number 9323-5312; UDI-DI 04719886908077; Lot number 25FC64

Quantity recalled3

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2898-2026
FDA event ID: 99025
Recalling firm: United Orthopedic, Kaohsiung
Classification: Class II
Status: Ongoing
Recall initiated: 19 Mar 2026
FDA classified: 6 Aug 2026
Reported: 12 Aug 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Hip & Knee Implants

Timeline

19 Mar 2026	Recall initiated by company
6 Aug 2026	Classified by FDA	+140 days
12 Aug 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution in the states of Texas and Michigan.

Nationwide Michigan Texas

Questions about this recall

Why was it recalled?

Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.

Which lots are affected?

Lot Code: Product number 9323-5312; UDI-DI 04719886908077; Lot number 25FC64

Where was it sold?

US Nationwide distribution in the states of Texas and Michigan.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 99025

This product is part of a recall event; the main page for the event is U2 Total Knee System Femoral offset bushing recalled.

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide

More recalls from United Orthopedic

All 12

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral valgus offset adaptor, left recalled	United Orthopedic	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	Ustar II Knee System Hinge Box Trial, L, #1 recalled	United Orthopedic	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	U2 Total Knee System PSA Box Trial, L, #1 recalled by United Orthopedic	United Orthopedic	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral valgus adaptor, left and right recalled	United Orthopedic	Device Malfunction	Nationwide

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral valgus offset adaptor, left recalled	United Orthopedic	Device Malfunction	Nationwide