Biomet Spine, LLC recalls Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusab…

Recall date

July 22, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2759-2015

FDA classification

Class II

Brand / firm

Biomet Spine, LLC

Sold / distributed

Worldwide Distribution: US (nationwide) in states of: NY, MO, WI, IN, CA, NC, and OH, and to countries of: Japan and Netherlands.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.