FDA-Device2015-05-06Class II
4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe Anterior Cervical Plating System REF 71240-14 LOT XXXXXX Alphatec Spine, Inc. EN: 4.0MM Variable Angle, Self--Drilling Hexalobe Screw, 14MM (TI-6AL-4V ELI) NON STERILE Single Use Only
Alphatec Spine, Inc.
Hazard
During a field audit it was discovered by an employee that a 16mm Trestle Luxe Screw has been both laser marked and labeled as a 14mm Trestle Luxe Screw (4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm). As a result the firm recalling the affected lots codes for this mislabeling.
Sold states
Worldwide Distribution - US Distribution to the states of: KS, LA, TN, NJ, KY, CA, FL, OR, OK, AZ, WI, CO, IN, NH, AR, UT, and AL., and to the countries of : Spain, Japan, Belgium, and Saudi Arabia.
Affected count
(244 units in US and 61 units OUS)
Manufactured in
5818 El Camino Real, Carlsbad, CA, United States
Products
4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe Anterior Cervical Plating System REF 71240-14 LOT XXXXXX Alphatec Spine, Inc. EN: 4.0MM Variable Angle, Self--Drilling Hexalobe Screw, 14MM (TI-6AL-4V ELI) NON STERILE Single Use Only
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1547-2015Don't want to check this manually?
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