FDA-Device2019-06-12Class II
Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the craniocervical junction, also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to per
Zimmer Biomet, Inc.
Hazard
Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.
Sold states
US Distribution to CA, NC, and NY; and International to Germany.
Affected count
64
Manufactured in
1800 W Center St, Warsaw, IN, United States
Products
Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the craniocervical junction, also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1735-2019Don't want to check this manually?
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