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Terminated

Guardian Distal Femur Axial Pin

FDA Recall Z-0523-06 · Posted 2006-02-16

Recalling FirmWright Medical Technology Inc
Recall StatusTerminated
Product CodeJDI
Date Initiated2006-01-03
Date Terminated2007-01-29
Product Quantity10

Reason for Recall

The product was not fully assembled prior to packaging.

Firm Action

The firm sent out recall notices to implanting surgeons by letter dated 01/10/2005 to notify the surgeons of the issue.

Root Cause

Other

Distribution Pattern

Nationwide and PR

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.

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