PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 12, 2019 Initiated: November 14, 2018 #Z-1735-2019

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
64
Distribution
US Distribution to CA, NC, and NY; and International to Germany.
Location
Warsaw, IN

Frequently Asked Questions

What product 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.. Recalled by Zimmer Biomet, Inc.. Units affected: 64.
Why was this product recalled? ▼
Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 12, 2019. Severity: Moderate. Recall number: Z-1735-2019.

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