FDAFDA · Food and drugs·Recall number Z-0203-2016
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.
Published November 11, 2015 · Recall initiated: September 29, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet Spine, LLC
- Distributor
- US Distribution to the states of : NY, MO, and FL
- Lot
- P/N: 14-521550; Lot Numbers: 463870; P/N: 14-521548; Lot Numbers: J86056; P/N: 14-521518; Lot Numbers: J26394; Model Numbers: 14-521518 14-521520 14-521548 14-521550
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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