Linvatec Corp. dba ConMed Linvatec – FDA 483, Mar 24, 2026
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.
ID · bc3aee15-fbcd-4b04-bd90-577274ebec0e
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