Z-0523-06

Guardian Distal Femur Axial Pin

Name: Z-0523-06 Guardian Distal Femur Axial Pin
Creator: Wright Medical Technology Inc
Published: 2006-01-03
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2006-01-03 / Terminated / root cause: packaging

FDA source

Wright Medical Technology Inc began a recall of Guardian Distal Femur Axial Pin on 2006-01-03. The reason FDA records is "The product was not fully assembled prior to packaging". 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-0523-06
Status: Terminated
Initiated: 2006-01-03
Posted: 2006-02-16
Terminated: 2007-01-29
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: The product was not fully assembled prior to packaging.
Root cause tag: packaging
FDA root cause: Other
Action: The firm sent out recall notices to implanting surgeons by letter dated 01/10/2005 to notify the surgeons of the issue.
Quantity in commerce: 10
Distribution: Nationwide and PR
Product codes and lots: Lot Nos. 75258083 and 7521663501

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)