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Devices
COLORADO 2" SPINAL SYSTEM
Model / Serial
Lot Numbers: W07G2386, W07G2387, W07G2388, W07G2389, W07G2751, W07H0440, W07H1809, and W07H1810.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution - USA, Australia, Hong Kong and the Netherlands.
Product Description
Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111, Medtronic, Memphis, TN 38138.
Manufacturer
Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
1 Event
Recall of COLORADO 2" SPINAL SYSTEM
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Manufacturer
Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
Manufacturer Address
Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK, 2500 Silveus Crossing, Warsaw IN 46582-8598
Source
USFDA
Language
English
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