# FDA 483 - Zimmer, Inc. - June 20, 2013

Source: https://www.keypedia.com/records/483/zimmer-inc/0034d134-bf78-4508-8edb-a9b29a73e2aa

> FDA 483 for Zimmer, Inc. on June 20, 2013. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zimmer, Inc.
- Inspection Date: 2013-06-20
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Zimmer, Inc. in Warsaw, IN, received an FDA Form 483 citing multiple quality system deficiencies. The observations highlight inadequate corrective and preventive actions, unvalidated manufacturing and packaging processes, and failures in design control for their NexGen femoral implants. These issues have led to product quality problems such as implant residue and incompatible implant combinations, with potential for patient harm and revision surgeries.

## Related Documents

- [483 - 2011-07-22](https://www.keypedia.com/records/483/zimmer-inc/d074b6c4-b721-458c-911a-34e5739a4d1e)
- [483 - 2012-05-21](https://www.keypedia.com/records/483/zimmer-inc/24d511af-eff9-48b7-862b-e42abb40ff65)

## Related Officers

- [Medical Device Senior Operations Officer at FDA](https://www.keypedia.com/people/thomas-a-peter/48a36892-cc03-42bb-8960-978d18f2147a)
- [investigator](https://www.keypedia.com/people/sargum-c-sood/980cd904-0fac-488d-8ea9-39a44d8ea21d)
- [Brian M. Campbell](https://www.keypedia.com/people/brian-m-campbell/b8924947-0eb2-4402-ae59-3e4960f77168)

Company: https://www.keypedia.com/companies/zimmer-inc/3bfeea91-979b-4daf-94f9-9b0c57c5e234

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0