CLASS II ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report
Ustar II Knee System Hinge Box Trial, L, #1 recalled
United Orthopedic is recalling Ustar II Knee System Hinge Box Trial, L, #1-6 and Hinge 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-2884-2026
- 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: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 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 9325-5711; UDI-DI 04719886907032; Lot number 25FB41 Product number 9325-5712; UDI-DI 04719886907049; Lot number 25FB42 Product number 9325-5713; UDI-DI 04719886907056; Lot number 25FB43 Product number 9325-5714; UDI-DI 04719886907063; Lot number 25FB44 Product number 9325-5715; UDI-DI 04719886907070; Lot number 25FB45 Product number 9325-5716; UDI-DI 04719886907087; Lot number 25FB46 Product number 9325-5721; UDI-DI 04719886907094; Lot number 25FB35 Product number 9325-5722; UDI-DI 04719886907100; Lot number 25FB36 Product number 9325-5723; UDI-DI 04719886907117; Lot number 25FB37 Product number 9325-5724; UDI-DI 04719886907124; Lot number 25FB38 Product number 9325-5725; UDI-DI 04719886907131; Lot number 25FB39 Product number 9325-5726; UDI-DI 04719886907148; Lot number 25FB40
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 | U2 Total Knee System PSA Box Trial, L, #1 recalled by United Orthopedic | 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 | 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 |
| 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 |