Recall Z-1465-2015— Biomet Spine, LLC

Name: FDA recall Z-1465-2015
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: 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.. 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

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.

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.