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