483
Orthosoft, Inc.Orthosoft, Inc. – FDA 483, Feb 14, 2019
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.
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ID · aa9a6b49-6e7c-46b0-b342-353ec3af904a
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