Z-0568-03

Hip Prosthesis as a component of Primaloc Cemented Hip System

Name: Z-0568-03 Hip Prosthesis as a component of Primaloc Cemented Hip System
Creator: Ortho Development Corporation
Published: 2002-12-26
License: https://open.fda.gov/license/

Ortho Development Corp. / initiated 2002-12-26 / Terminated / root cause: packaging

FDA source

Ortho Development Corporation began a recall of Hip Prosthesis as a component of Primaloc Cemented Hip System on 2002-12-26. The reason FDA records is "Cleaning agent residue from packaging material was adhering to implantable hip stems". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0568-03
Status: Terminated
Initiated: 2002-12-26
Posted: 2003-02-25
Terminated: 2003-04-22
Recalling firm: Ortho Development Corp.
Product: Hip Prosthesis as a component of Primaloc Cemented Hip System.
Reason for recall: Cleaning agent residue from packaging material was adhering to implantable hip stems.
Root cause tag: packaging
FDA root cause: Other
Action: Consignees were notified on 12/26/2002 via telephone and e-mail.
Quantity in commerce: 41
Distribution: TX and Japan
Product codes and lots: 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.

K962448Class IIPrimaloc Cemented Hip SystemOrtho Development Corp. / cleared 1996-09-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)