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Zimmer Biomet, Inc. recalls Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobi
Recalled June 12, 2019 · FDA recall Z-1735-2019 · Zimmer Biomet
Hazard
Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking. · FDA Class II
Units
64
Sold at
US Distribution to CA, NC, and NY; and International to Germany.
Description
Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.
Product
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.
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →