United Orthopedic Corp. — Class II: Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Mo
United Orthopedic Corp. initiated a Class II recall for femoral valgus adaptors (left and right) within the U2 Total Knee System. The recall was prompted by an incomplete component screw process performed by a subcontractor, which prevents proper assembly of the stem trail.
Manufacturers of orthopedic surgical instruments, particularly those utilizing subcontractors for component machining, and clinical staff utilizing the U2 Total Knee System models 9323-5333 and 9323-5334.
This incident underscores the risks associated with subcontractor oversight and the criticality of component-level quality control. Failure to properly assemble surgical instrumentation during a procedure could lead to delays or surgical complications. It suggests a potential gap in the validation of outsourced manufacturing processes or inadequate final inspection of the assembly interface.
QA teams should verify that incoming inspection protocols for surgical instrument components effectively detect threading or assembly deviations. Supply chain managers should review subcontractor quality agreements to ensure specialized processing steps are adequately validated and verified.
Class II. Reason: Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.. Product: 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. Firm: United Orthopedic Corp. (Kaohsiung Taiwan). Status: Ongoing.
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