FDA Inspection
Zimmer Biomet CMF and Thoracic LLCZimmer Biomet CMF and Thoracic LLC – FDA Inspection, May 24, 2018
Record Details
This FDA Inspection record concerns Zimmer Biomet CMF and Thoracic LLC, with an inspection on May 24, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 72ed293c-e977-4942-9003-1d7ce2b7c511
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1053122
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 803.50(a)(2)Individual Report of Malfunction
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Zimmer Biomet CMF and Thoracic LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 4, 2025 | VAI | Florida District Office | Compliance: Medical Devices |
| September 1, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 30, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 17, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Zimmer Biomet CMF and Thoracic LLC
- FDA Inspection 1262841 - 2025-03-04
- FDA Inspection 1024178 - 2017-09-01
- FDA Inspection 947565 - 2015-10-30
- FDA Inspection 764538 - 2012-01-17
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