CLASS II ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report
U2 Total Knee System Femoral valgus adaptor, left and right recalled
United Orthopedic is recalling U2 Total Knee System Femoral valgus adaptor, left and right, distributed nationwide in the US. The recall was initiated on 20 May 2026 and the FDA has classified it as Class II.
Check your package
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-2885-2026
- FDA event ID
- 99026
- Recalling firm
- United Orthopedic, Kaohsiung
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 May 2026
- FDA classified
- 5 Aug 2026
- Reported
- 12 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 20 May 2026 | Recall initiated by company | |
| 5 Aug 2026 | Classified by FDA | +77 days |
| 12 Aug 2026 | Published in enforcement report | +7 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 an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
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 valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
Where it was distributed
US Nationwide distribution in the states of Texas and Michigan.
Questions about this recall
Why was it recalled?
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Which lots are affected?
Product Number; UDI-DI Code; Lot Code: Product number 9323-5333; UDI-DI 04719886908084; Lot number 25FB50 Product number 9323-5334; UDI-DI 04719886908091; Lot number 25FB51
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
3 other products · FDA event 99026| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | U2 Total Knee System PSA Box Trial, L, #1 recalled by United Orthopedic | United Orthopedic | Device Malfunction | Nationwide | |
| CLASS II | Ustar II Knee System Hinge Box Trial, L, #1 recalled | United Orthopedic | Device Malfunction | Nationwide | |
| CLASS II | U2 Total Knee System Femoral valgus offset adaptor, left recalled | United Orthopedic | Device Malfunction | Nationwide |
More recalls from United Orthopedic
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |
| Device | CLASS II | U2 Total Knee System Femoral valgus offset adaptor, left recalled | United Orthopedic | Device Malfunction | Nationwide |
| Device | CLASS II | Ustar II Knee System Hinge Box Trial, L, #1 recalled | United Orthopedic | Device Malfunction | Nationwide |
| Device | CLASS II | U2 Total Knee System PSA Box Trial, L, #1 recalled by United Orthopedic | United Orthopedic | Device Malfunction | Nationwide |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |