FDA-Device2015-04-29Class II

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.

Biomet Spine, LLC
Hazard

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.

Sold states
Worldwide Distribution - US Nationwide
Affected count
148
Manufactured in
310 Interlocken Pkwy Ste 120, Broomfield, CO, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1465-2015

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