# FDA 483 - Linvatec Corp. dba ConMed Linvatec - March 24, 2026

Source: https://www.keypedia.com/records/483/linvatec-corp-dba-conmed-linvatec/bc3aee15-fbcd-4b04-bd90-577274ebec0e

> FDA 483 for Linvatec Corp. dba ConMed Linvatec on March 24, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Linvatec Corp. dba ConMed Linvatec
- Inspection Date: 2026-03-24
- Product Type: device
- Office Name: Florida District Office
- Summary: 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.

## Related Officers

- [Monica C. Burgos Garcia](https://www.keypedia.com/people/monica-c-burgos-garcia/d73d6ad6-4158-4c12-a0bf-6f5721db3400)
- [Lorraine N. Williams](https://www.keypedia.com/people/lorraine-n-williams/f02f9092-4aa9-4def-9b9f-fca1c850cd00)

Company: https://www.keypedia.com/companies/linvatec-corp-dba-conmed-linvatec/1d0160a2-7161-4890-a723-4929d6219435

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9