Home / Recalls / Medical Devices
Biomet Spine, LLC recalls MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate
Recalled November 11, 2015 · FDA recall Z-0203-2016 · Biomet Spine
Hazard
The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws. · FDA Class II
Units
17 units
Sold at
US Distribution to the states of : NY, MO, and FL
Description
The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.
Product
MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.
Manufacturer(s)
Biomet Spine, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →