Zimmer Biomet, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1735-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 14, 2018

Date Posted: June 12, 2019

Recall Number: Z-1735-2019

Event ID: 82856

Reason for Recall:

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

Status: Terminated

Product Quantity: 64

Code Information:

Lot M26888

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated