# Kyocera Corporation · 89-08 · JAPAN — FDA import alert red lists: firms subject to detention without physical examination

For Kyocera Corporation · 89-08 · JAPAN, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is JAPAN; product code is 87 L - - ZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented; date published is 09/16/2009; address is 10 1 , Kawai; Gamo-Chogamo Block, , Gamogun, Shiga JAPAN, verified against its source on 2026-09-16.

- **Firm:** Kyocera Corporation _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** JAPAN _(verified: appears in the quote below)_
- **Address:** 10 1 , Kawai; Gamo-Chogamo Block, , Gamogun, Shiga JAPAN _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 87 L - - ZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented _(verified: appears in the quote below)_
- **FDA notes:** Ceramic Aluminum and Zirconium Balls for Hip Implants 1/13/2005 _(verified: appears in the quote below)_

## What the source says

> Kyocera Corporation Date Published : 09/16/2009 10 1 , Kawai; Gamo-Chogamo Block, , Gamogun, Shiga JAPAN 87 L - - ZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented Date Published: 09/16/2009 Notes: Ceramic Aluminum and Zirconium Balls for Hip Implants 1/13/2005

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).