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Recall Observatory FDA recall evidence

Device 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.

Z-1735-2019

November 14, 2018

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 82856
Status
Terminated
Classification
Class II
Quantity
64
Official record key
device-enforcement:Z-1735-2019

Official wording

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

Code information: Lot M26888

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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