Orthosoft, Inc. dba Zimmer CASFebruary 14, 2019

FDA 483 - Orthosoft, Inc. dba Zimmer CAS - February 14, 2019

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Record Details

An FDA inspection of Orthosoft, Inc. dba Zimmer CAS, a medical device manufacturer in Montreal, revealed a significant issue with design validation. The firm failed to adequately validate a design change for its iASSIST Validation Tool, resulting in an increased number of product complaints related to bent or broken drive pins. This indicates a deficiency in ensuring product performance and safety after modifications.

Company: Orthosoft, Inc. dba Zimmer CAS
Inspection Date: February 14, 2019
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Brian S. Keefer (Investigator at US Food and Drug Administration)

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ID · aa9a6b49-6e7c-46b0-b342-353ec3af904a