FDA Device recall Z-1735-2019
Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabiliza…
- FDA Device
- Class II
- terminated
- Published 2019-06-12
On 2019-06-12 the FDA classified a Class II recall of Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabiliza… by Zimmer Biomet, citing etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1735-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-14 |
| Published | 2019-06-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Zimmer Biomet |
| Distribution | CA, NC, NY |
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.
Reason
Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.
Identifiers
| code_info | Lot M26888 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1735-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.