Lineum 4 — Class II medical device recall Z-1735-2019
Terminated recall by Zimmer Biomet, Inc., reported 2019-06-12, distributed in CA, NC, NY. Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.
| Recall number | Z-1735-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-11-14 |
| Classified | 2019-06-05 |
| Reported by FDA | 2019-06-12 |
| Terminated | 2020-05-12 |
| Distributed | CA, NC, NY |
| Countries outside the US | DE |
| Quantity | 64 |
| Lot numbers | M26888 |
| Model numbers | 14-524728 |
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 for recall
Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1735-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.