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Devices
Device Recall Invue Screws
Model / Serial
Lot/Serial Number: IM71 059-01: Lot 0000 lM71059-02; IM71059-02: Lot 035M
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.
Product Description
Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. || Used to secure the Invue Anterior Cervical Plate in position.
Manufacturer
SpineFrontier, Inc.
1 Event
Recall of Device Recall Invue Screws
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Manufacturer
SpineFrontier, Inc.
Manufacturer Address
SpineFrontier, Inc., 500 Cummings Ctr Ste 3500, Beverly MA 01915-6516
Manufacturer Parent Company (2017)
SpineFrontier, Inc.
Source
USFDA
3 devices with a similar name
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Device Recall Invue Screws
Model / Serial
Lot/Serial Number: IM71058-0l: Lot 0000; IM71058-02: Lot 0000; IM71058-03 : Lot 0000
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.
Product Description
Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. || Used to secure the Invue Anterior Cervical Plate in position.
Manufacturer
SpineFrontier, Inc.
Device Recall Invue Screws
Model / Serial
Lot/Serial Number: IM71 0 16-01: Lots 0000, 000 1
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.
Product Description
Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. || Used to secure the Invue Anterior Cervical Plate in position.
Manufacturer
SpineFrontier, Inc.
Device Recall Invue Screws
Model / Serial
Lot/Serial Number: IM71013-01: Lot 0000
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.
Product Description
Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. || Used to secure the Invue Anterior Cervical Plate in position.
Manufacturer
SpineFrontier, Inc.
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