Colorado 2 Spinal System, Anterior Plate, REF8639500, for export only, manufactured at: Warsaw, Indiana USA, Rx only
FDA device recall Z-0653-2007 · posted 2007-03-27 · Terminated
Recall details
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Reason for recall
- Bone screws may pull though the plate.
- Action taken
- 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
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 1407 units
- Distribution
- France, Germany, Italy, UK, and Tunisia. No US distribution.
- Date initiated
- 2007-02-02
- Date posted
- 2007-03-27
- Date terminated
- 2007-08-11
- Location
- Memphis, TN
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