FDA 483 - Linvatec Corp. dba ConMed Linvatec - March 24, 2026
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The FDA inspected Linvatec Corp. dba ConMed Linvatec in Largo, FL, and found significant deficiencies in their quality management system for reusable powered surgical instruments. The firm failed to apply a risk-based approach to systemic quality issues, leading to a chronic pattern of ineffective corrective actions and a failure to integrate quality data. This resulted in the inadequate control of nonconforming products and manufacturing processes, with defective motor components being released and field failures continuing unaddressed.
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