Alphatec Spine product recalled over labeling errors

Recall date

April 10, 2015

Source

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

Official notice title

Alphatec Spine, Inc. recalls 4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe Ante…

Recall number

Z-1547-2015

FDA classification

Class II

Brand / firm

Alphatec Spine, Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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