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

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.