Medtronic Sofamor Danek USA Inc Colorado 2 Spinal System, Anterior Plate, REF8639500, for export only, manufactured at: Warsaw, Indiana USA, Rx only Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Colorado 2 Spinal System, Anterior Plate, REF8639500, for export only, manufactured at: Warsaw, Indiana USA, Rx only
Brand
Medtronic Sofamor Danek USA Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
Medtronic Sofamor Danek USA Inc is recalling Colorado 2 Spinal System, Anterior Plate, REF8639500, for export only, manufactured at: Warsaw, Ind due to Bone screws may pull though the plate.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Bone screws may pull though the plate.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026