Biomet Spine, LLC recalls Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facilitate reconstruction of…

Recall date

March 12, 2015

Source

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

Recall number

Z-1465-2015

FDA classification

Class II

Brand / firm

Biomet Spine, LLC

Sold / distributed

Worldwide Distribution - US Nationwide

Why it was recalled

Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for component updates or reconfiguration.

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

What was recalled

Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facilitate reconstruction of the cervical and upper thoracic spine using bones screws, locking plugs, and various types of rods, hooks, and lateral connectors.