Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner… — Class II medical device recall Z-2759-2015
Terminated recall by Biomet Spine, LLC, reported 2015-09-16, distributed nationwide. Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft instrumentsafter
| Recall number | Z-2759-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet Spine, LLC, Broomfield, CO, United States |
| Recall initiated | 2015-07-22 |
| Classified | 2015-09-10 |
| Reported by FDA | 2015-09-16 |
| Terminated | 2015-12-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP, NL |
| Quantity | 49 |
| Lot numbers | 001219, 001220, 14-525057 |
| Model numbers | 14-525050, 14-525057 |
Product
Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic spine using bone screws, locking plugs, and various types of rods, hooks, and lateral connectors. One of the instruments used with this system is the Lineum Occipital Screw Starter with the inner shaft subassembly. The system comes with a fixed shaft Lineum Occipital Screw Driver, and a 90¿ driver in order to retain and drive the screw into the occipital bone.
Reason for recall
Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft instrumentsafter identifying that these instruments were distributed prior to completion of all design control activities.
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-2759-2015. 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.