Z-1405-04

Guardian Distal Femur Axial Pin

Name: Z-1405-04 Guardian Distal Femur Axial Pin
Creator: Wright Medical Technology Inc
Published: 2004-07-14
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2004-07-14 / Terminated

FDA source

Wright Medical Technology Inc began a recall of Guardian Distal Femur Axial Pin on 2004-07-14. The reason FDA records is "Potential for self -locking axial pin to dislodge and 'back out'". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1405-04
Status: Terminated
Initiated: 2004-07-14
Posted: 2004-08-24
Terminated: 2005-07-05
Recalling firm: Wright Medical Technology Inc
Product: Guardian Distal Femur Axial Pin
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Potential for self -locking axial pin to dislodge and 'back out'.
FDA root cause: Other
Action: The firm sent out product correction notifications to implanting surgeons by letter dated 07/14/2004 to notify the surgeons of the dislodgement issue.
Quantity in commerce: 44
Distribution: Nationwide. Ontario, and Taiwan, ROC
Product codes and lots: Part No. 25002111, Serial No. 02217952 Part No. 25002112, Serial No. 01214391 Part No. 25002112, Serial No. 01215073 Part No. 25002113, Serial No. 01214533 Part No. 25002114, Serial No. 01215034 Part No. 25002114, Serial No. 01215074

Product code JDI

K013035Class IIGuardian Limb Salvage SystemWrightmedicaltechnologyinc / cleared 2001-12-07

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)