Zimmer Biomet, Inc. recalls Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobili…

Recall date

November 14, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1735-2019

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

US Distribution to CA, NC, and NY; and International to Germany.

Why it was recalled

Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.