Recall Z-1466-2015— Biomet Spine, LLC

Name: FDA recall Z-1466-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-12

Class II · Terminated

Class II FDA medical device recall by Biomet Spine, LLC, initiated 2015-03-12, terminated 2015-09-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous fixation device.. Reason: 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..

Recalling firm: Biomet Spine, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-03-12
Terminated: 2015-09-16
Firm location: Broomfield, CO, United States

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.