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Devices
Satellite (Medtronic Sofamor Danek) Satellite Sphere CoCr
Model / Serial
ALL LOTS to include: W05K0556, W05K1614, W06A3260
Product Classification
Orthopedic Devices
Device Class
Unclassified
Implanted device?
Yes
Distribution
Nationwide
Product Description
Medtronic Sofamor Danek, 9 mm Satellite Sphere CoCr, Size 9 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000209, Manufactured at: Warsaw, Indiana, USA
Manufacturer
Medtronic Sofamor Danek USA Inc
1 Event
Recall of Satellite (Medtronic Sofamor Danek) Satellite Sphere CoCr
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Manufacturer
Medtronic Sofamor Danek USA Inc
Manufacturer Address
Medtronic Sofamor Danek USA Inc, 1800 Pyramid Place, Memphis TN 38132-1719
Source
USFDA
6 devices with a similar name
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Satellite (Medtronic Sofamor Danek) Satellite Sphere CoCr
Model / Serial
ALL LOTS to include: W05K0541, W05K0542, W05K0550, W05K0551, W05K0558, W05K0731, W06A0842
Product Classification
Orthopedic Devices
Device Class
Unclassified
Implanted device?
Yes
Distribution
Nationwide
Product Description
Medtronic Sofamor Danek, 12 mm Satellite Sphere CoCr, Size 12 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000212, Manufactured at: Warsaw, Indiana, USA
Manufacturer
Medtronic Sofamor Danek USA Inc
Satellite (Medtronic Sofamor Danek) Satellite Sphere CoCr
Model / Serial
ALL LOTS to include: W05K0132, W05K0557, W05K1576, W05K1595, W05K2449, W06A0915
Product Classification
Orthopedic Devices
Device Class
Unclassified
Implanted device?
Yes
Distribution
Nationwide
Product Description
Medtronic Sofamor Danek, 13 mm Satellite Sphere CoCr, Size 13 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000213, Manufactured at: Warsaw, Indiana, USA
Manufacturer
Medtronic Sofamor Danek USA Inc
Satellite (Medtronic Sofamor Danek) Satellite Sphere CoCr
Model / Serial
ALL LOTS to include: W05K0561, W05K0582, W05K1920, W06A2074, W07H0210
Product Classification
Orthopedic Devices
Device Class
Unclassified
Implanted device?
Yes
Distribution
Nationwide
Product Description
Medtronic Sofamor Danek, 14 mm Satellite Sphere CoCr, Size 14 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000214, Manufactured at: Warsaw, Indiana, USA
Manufacturer
Medtronic Sofamor Danek USA Inc
Satellite (Medtronic Sofamor Danek) Satellite Sphere CoCr
Model / Serial
ALL LOTS to include: W05K0134, W05K0543, W05K0560, W05K0565, W05K1572, W05K1573, W05K1575
Product Classification
Orthopedic Devices
Device Class
Unclassified
Implanted device?
Yes
Distribution
Nationwide
Product Description
Medtronic Sofamor Danek, 10 mm Satellite Sphere CoCr, Size 10 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000210, Manufactured at: Warsaw, Indiana, USA
Manufacturer
Medtronic Sofamor Danek USA Inc
Satellite (Medtronic Sofamor Danek) Satellite Sphere CoCr
Model / Serial
ALL LOTS to include: W05K0144, W05K0552, W05K0553, W05K0554, W05K0567, W05K0572, W05K0722
Product Classification
Orthopedic Devices
Device Class
Unclassified
Implanted device?
Yes
Distribution
Nationwide
Product Description
Medtronic Sofamor Danek, 11 mm Satellite Sphere CoCr, Size 11 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000211, Manufactured at: Warsaw, Indiana, USA
Manufacturer
Medtronic Sofamor Danek USA Inc
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