FDA Medical Device Recalls (openFDA)
Ortho Development Corporation: Hip Prosthesis as a component of Primaloc Cementless/Collared Hip System.
- Recall number
- Z-0566-03
- Recalling firm
- Ortho Development Corporation
- Product
- Hip Prosthesis as a component of Primaloc Cementless/Collared 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
- 78
- Distribution
- TX and Japan
- Lot, serial or model codes
- Catalog # 112-0915, Lot # OD-18031, W003152, WO#003152. Catalog # 112-0917, Lot # OD-19103-1, OD-20567, W0#003109. Catalog # 112-1015, Lot # OD-19038, W0#003155. Catalog # 112-1017, Lot # OD-17403. Catalog # 112-1115, Lot # WO#003045. Catalog # 112-1117, Lot # OD-23210, OD-23211. Catalog # 112-1119, Lot # OD-23232. Catalog # 112-1217, Lot # OD-23206. Catalog # 112-1219, Lot # OD-23233. Catalog # 112-1221, Lot # OD-23252 Catalog # 112-1223, Lot # OD-17321, W003725, WO#003350. Catalog # 112-1319, Lot # OD-20572, OD-20867-1, OD-23234, OD-23234-1, OD-23246. Catalog # 112-1321, Lot # OD-23253. Catalog # 112-1421, Lot # OD-23248, OD-23248-1, OD-23251, OD-23251-1. Catalog # 112-1425, Lot # OD-21874. Catalog # 112-1623, Lot # OD-21147-1. Catalog # 112-1625, Lot # W0#003130, WO#003139.
- 510(k) numbers
- ["K953977"]
- 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