FDA Medical Device Recalls (openFDA)
Ortho Development Corporation: Hip Prosthesis as a component of TriFix J Cemented Hip. (Manufactured for distribution in Japan only.)
- Recall number
- Z-0569-03
- Recalling firm
- Ortho Development Corporation
- Product
- Hip Prosthesis as a component of TriFix J Cemented Hip. (Manufactured for distribution in Japan only.)
- Status
- Terminated
- Initiated
- 2002-12-26
- Posted
- 2003-02-25
- Terminated
- 2003-04-22
- Reason
- Cleaning agent residue from packaging material was adhering to implantable hip stems.
- Root cause
- Other
- Action
- Consignees were notified on 12/26/2002 via telephone and e-mail.
- Quantity
- 14
- Distribution
- TX and Japan
- Lot, serial or model codes
- Catalog # 115-1015, Lot # W016134, W017080. Catalog # 115-1319, Lot # W016434.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 3017298928
- Firm city
- Draper
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28