FDA Medical Device Recalls (openFDA)
Ortho Development Corporation: Hip Prosthesis as a component of Primaloc Cemented Hip System.
- Recall number
- Z-0568-03
- Recalling firm
- Ortho Development Corporation
- Product
- Hip Prosthesis as a component of Primaloc Cemented Hip System.
- 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
- 41
- Distribution
- TX and Japan
- Lot, serial or model codes
- Catalog # 114-0917, Lot # OD-18030-5, W003600, W003601, W003602. Catalog # 114-1017, Lot # OD-18563, OD-18563-1, OD-23190, OD-23191, OD-23221. Catalog # 114-1219, Lot # OD-23192, OD-23192-1, OD-23193, OD-23194. Catalog # 114-1421, Lot # OD-17306, OD-17412. Catalog # 114-1623, Lot # W0#003264, W003614.
- 510(k) numbers
- ["K962448"]
- 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