Z-1735-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2019
- Initiation Date
- November 14, 2018
- Termination Date
- May 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64
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.
Distribution Pattern
US Distribution to CA, NC, and NY; and International to Germany.
Code Information
Lot M26888