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FDAJuly 22, 2015device

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 scr...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

biomet spinebiomet

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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