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Devices
Medtronic Sofamor Danek, Satellite System Sphere PEEK
Model / Serial
ALL LOTS to include: LX57, LX63, MA71, MG77, NB29, NE31
Product Classification
Orthopedic Devices
Device Class
Unclassified
Implanted device?
Yes
Distribution
Nationwide
Product Description
Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 15 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000215, Manufactured at: Warsaw, Indiana, USA
Manufacturer
Medtronic Sofamor Danek USA Inc
1 Event
Recall of Medtronic Sofamor Danek, Satellite System Sphere PEEK
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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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Medtronic Sofamor Danek, Satellite System Sphere PEEK
Model / Serial
ALL LOTS to include: LX52, MA67
Product Classification
Orthopedic Devices
Device Class
Unclassified
Implanted device?
Yes
Distribution
Nationwide
Product Description
Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 10 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000210, Manufactured at: Warsaw, Indiana, USA
Manufacturer
Medtronic Sofamor Danek USA Inc
Medtronic Sofamor Danek, Satellite System Sphere PEEK
Model / Serial
ALL LOTS to include: LX53, LX59,MG73, MY47, MY49, NC36, ND61, NE27
Product Classification
Orthopedic Devices
Device Class
Unclassified
Implanted device?
Yes
Distribution
Nationwide
Product Description
Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 11 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000211, Manufactured at: Warsaw, Indiana, USA
Manufacturer
Medtronic Sofamor Danek USA Inc
Medtronic Sofamor Danek, Satellite System Sphere PEEK
Model / Serial
ALL LOTS to include: LX54, LX60, MA68, MG74, NB26, NE28, NF61
Product Classification
Orthopedic Devices
Device Class
Unclassified
Implanted device?
Yes
Distribution
Nationwide
Product Description
Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 12 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000212, Manufactured at: Warsaw, Indiana, USA
Manufacturer
Medtronic Sofamor Danek USA Inc
Medtronic Sofamor Danek, Satellite System Sphere PEEK
Model / Serial
ALL LOTS to include: LX55, LX61, MA69, MG75, NB27, ND62, NE29, NF62
Product Classification
Orthopedic Devices
Device Class
Unclassified
Implanted device?
Yes
Distribution
Nationwide
Product Description
Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 13 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000213, Manufactured at: Warsaw, Indiana, USA
Manufacturer
Medtronic Sofamor Danek USA Inc
Medtronic Sofamor Danek, Satellite System Sphere PEEK
Model / Serial
ALL LOTS to include: LX56, LX62, MA70, MG76, NB28, ND63, NE30
Product Classification
Orthopedic Devices
Device Class
Unclassified
Implanted device?
Yes
Distribution
Nationwide
Product Description
Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 14 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000214, Manufactured at: Warsaw, Indiana, USA
Manufacturer
Medtronic Sofamor Danek USA Inc
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