Biomet Spine, LLC: Medical Device Recall in 2015 - (Recall #: Z-0203-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 29, 2015

Date Posted: November 11, 2015

Recall Number: Z-0203-2016

Event ID: 72312

Reason for Recall:

The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.

Status: Terminated

Product Quantity: 17 units

Code Information:

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

Distribution Pattern:

US Distribution to the states of : NY, MO, and FL

Voluntary or Mandated:

Voluntary: Firm initiated