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Devices
Fortex Pedicle Screw System Continuous Radius Rod 5.5 50mm, XSpine Systems, Inc.
Model / Serial
Model #: N60001068; Lot #: 2943-01; Serial #s: 46118, 46581, 47296, 47588, 47653, 48164, 48201, 48412, 49156, 49585, 49586, 49649, G22, G45, G47, G77, G83, G87X, G90X, R15, XP03, XP21, XP27, XP28, XP29 & XP32.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution - US Distribution to the states of : FL, ID, IL, KS, LA, MI, MO, NJ, OH, PA and TX., and to the countries of Austria, Germany and Italy.
Product Description
Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
Manufacturer
X Spine Systems Inc
1 Event
Recall of Fortex Pedicle Screw System Continuous Radius Rod 5.5 50mm, XSpine Systems, Inc.
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Manufacturer
X Spine Systems Inc
Manufacturer Address
X Spine Systems Inc, 452 Alexandersville Rd, Miamisburg OH 45342-3658
Manufacturer Parent Company (2017)
X-Spine Systems, Inc
Source
USFDA
Language
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