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

Source: https://www.globalkeysolutions.net/records/483/orthosoft-inc-dba-zimmer-cas/aa9a6b49-6e7c-46b0-b342-353ec3af904a

> FDA 483 for Orthosoft, Inc. dba Zimmer CAS on February 14, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Orthosoft, Inc. dba Zimmer CAS
- Inspection Date: 2019-02-14
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Investigator at US Food and Drug Administration](https://www.globalkeysolutions.net/people/brian-s-keefer/4fec578b-ca72-4d79-8634-3a9fe7ecd9a5)

Company: https://www.globalkeysolutions.net/companies/orthosoft-inc-dba-zimmer-cas/95c6ae7b-02cb-46a0-a2a0-3703a032ab3f

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd