Z-1735-2019 Class II Terminated
FDA device recall Z-1735-2019 was initiated by Zimmer Biomet, Inc. on Nov 14, 2018 and is designated Class II. Reason for recall: Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking. The recall status is terminated (terminated May 12, 2020). Affected quantity: 64.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 12, 2019
- Initiation Date
- Nov 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1735-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026