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Terminated

Colorado 2 Spinal System, Anterior Plate, REF8639500, for export only, manufactured at: Warsaw, Indiana USA, Rx only

FDA Recall Z-0653-2007 · Posted 2007-03-27

Recalling FirmMedtronic Sofamor Danek USA Inc
Recall StatusTerminated
Product CodeKWQ
Date Initiated2007-02-02
Date Terminated2007-08-11
Product Quantity1407 units

Reason for Recall

Bone screws may pull though the plate.

Firm Action

Medtronic Global Quality initiated the recall via letter on 02/02/2007. Sub-recalls will be managed by Medtronic EMEA quality (Europe, Middle East, and Africa) in the affected geographies. Distributors and surgical facilities will be contacted as well as regulatory bodies in each country.

Root Cause

Other

Distribution Pattern

France, Germany, Italy, UK, and Tunisia. No US distribution.

Official Source

View FDA Recall →

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

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