Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Guardian Distal Femur Axial Pin

FDA Recall Z-1405-04 · Posted 2004-08-24

Recalling FirmWright Medical Technology Inc
Recall StatusTerminated
Product CodeJDI
Date Initiated2004-07-14
Date Terminated2005-07-05
Product Quantity44

Reason for Recall

Potential for self -locking axial pin to dislodge and 'back out'.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide. Ontario, and Taiwan, ROC

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013035GUARDIAN LIMB SALVAGE SYSTEMWrightmedicaltechnologyinc · 2001-12-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑