Recall Z-1735-2019— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-11-14, terminated 2020-05-12. It names one FDA 510(k) clearance: K151224. 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..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-14
- Terminated
- 2020-05-12
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.