Kaohsiung, Taiwan
United Orthopedic Corp. recalls
4 recalls recorded since 2018, most recently on 20 May 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)3
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 20 May 2026
- Reason
- Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
- Distribution
- US Nationwide distribution in the states of Texas and Michigan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2885-2026, Z-2883-2026, Z-2884-2026, Z-2886-2026
- 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 Co
- 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:
- 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 Descripti
- Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5
Ongoing Class II Medical devices
- Recall started
- 19 March 2026
- Reason
- Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
- Distribution
- US Nationwide distribution in the states of Texas and Michigan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2897-2026, Z-2898-2026
- Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
- 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
Ongoing Class II Medical devices
- Recall started
- 3 January 2024
- Reason
- Their is a potential that the implant curved stem may be oriented incorrectly.
- Distribution
- US: CA,KY, MI, IN, TN, CO, FL, TX, NV, OUS: Switzerland, United Kingdom, Malaysia, Philippines, Taiwan
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1217-2024, Z-1215-2024, Z-1216-2024
- USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE25151115 - 15X125mm, PE25151117 - 17X125mm,
- USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm, PE11151213 - 13x150mm, PE11151215 - 15x150mm, PE11151217 - 17x150mm, PE11151411 - 11x200
- USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111- 11x125mm, PE25153115 - 15x125mm, PE25
Terminated Class II Medical devices
- Recall started
- 24 November 2017
- Terminated
- 9 October 2018
- Reason
- UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling.
- Distribution
- Worldwide Distribution - US Distribution and to the countries of: UK, Iran, Greece, Pakistan, Switzerland, France, China, Taiwan, Italy, Korea and South Africa.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1128-2018, Z-1129-2018
- U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee func
- U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.