Recalls / —

—#50447

Product

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

FDA product code

KWQ — Appliance, Fixation, Spinal Intervertebral Body

Device class

Class 2

Medical specialty

Orthopedic

Affected lot / code info

Lot Nos.: 42554, 59143, 74708, 076380, 076520, 81321, 82118, 82119, 82236, 83602, 83667, 98552, 177390, 177420, 229470, 230050, 365740, 662340, 685000, 857100, 877430, 909610, W05A1351, W05C5778, W05F5388, W05F5389, W05G1030, W05G2592, W05H1354, W05H7884, W05J1023, W05J1497, W05J1687, W05J2710, W05J2711, W05L0550, W05L1016, W06E3829, W06F4111, W06H1671, W06K1299, W06M1486, W06M1487.

Why it was recalled

Bone screws may pull though the plate.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Medtronic Sofamor Danek USA Inc

Address

1800 Pyramid Place, Memphis, Tennessee 38132-1719

Distribution

Distribution pattern

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

Timeline

Recall initiated

2007-02-02

Posted by FDA

2007-03-27

Terminated

2007-08-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #50447. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.