CLASS II ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report
U2 Total Knee System PSA Box Trial, L, #1 recalled by United Orthopedic
United Orthopedic is recalling U2 Total Knee System PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6, 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-2883-2026
- 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: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A
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 9323-5511; UDI-DI 04719886906929; Lot number 25FB54 Product Number 9323-5512; UDI-DI 04719886906936; Lot number 25FB55 Product Number 9323-5513; UDI-DI 04719886906943; Lot number 25FB56 Product Number 9323-5514; UDI-DI 04719886906950; Lot number 25FB57 Product Number 9323-5515; UDI-DI 04719886906967; Lot number 25FB58 Product Number 9323-5516; UDI-DI 04719886906424; Lot number 25FB59 Product Number 9323-5521; UDI-DI 04719886906974; Lot number 25FB29 Product Number 9323-5522; UDI-DI 04719886906981; Lot number 25FB30 Product Number 9323-5523; UDI-DI 04719886906998; Lot number 25FB31 Product Number 9323-5524; UDI-DI 04719886907001; Lot number 25FB32 Product Number 9323-5525; UDI-DI 04719886907018; Lot number 25FB33 Product Number 9323-5526; UDI-DI 04719886907025; Lot number 25FB34
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 99026This product is part of a recall event; the main page for the event is U2 Total Knee System Femoral valgus adaptor, left and right recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | U2 Total Knee System Femoral valgus adaptor, left and right recalled | 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 Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |
| Device | CLASS II | U2 Total Knee System Femoral valgus adaptor, left and right recalled | United Orthopedic | Device Malfunction | Nationwide |
Other Hip & Knee Implants recalls
All 3,111| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intellijoint Navigation System: Workstation G2 Configured recalled | Intellijoint Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |