FDA-Device2014-01-01Class II

Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical Plate in position.

SpineFrontier, Inc.
Hazard

Mismarked and unmarked screws

Sold states
Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.
Affected count
N/A
Manufactured in
500 Cummings Ctr Ste 3500, N/A, Beverly, MA, United States
Products
Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical Plate in position.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0575-2014

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