Biomet Spine, LLC recalls Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cer…

Recall date

March 12, 2015

Source

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

Recall number

Z-1466-2015

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

Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous fixation device.