Recall Z-2886-2026— United Orthopedic Corp.
Class II · Ongoing
Class II FDA medical device recall by United Orthopedic Corp., initiated 2026-05-20. FDA's recall record names no specific 510(k) clearance for this event. Product: 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 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No. Reason: Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail..
- Recalling firm
- United Orthopedic Corp.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-05-20
- Firm location
- Kaohsiung, Taiwan
Product description
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 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
Reason for recall
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Data sourced from openFDA. This site is unofficial and independent of the FDA.