Recall Z-0203-2016— Biomet Spine, LLC

Name: FDA recall Z-0203-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-29

Class II · Terminated

Class II FDA medical device recall by Biomet Spine, LLC, initiated 2015-09-29, terminated 2016-04-29. It names 2 FDA 510(k) clearances: K133518, K080646. 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.. Reason: The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws..

Recalling firm: Biomet Spine, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-09-29
Terminated: 2016-04-29
Firm location: Broomfield, CO, United States

510(k) clearances named in this recall

2 on FDA's record

K133518 — MAXAN ANTERIOR CERVICAL PLATE SYSTEMBiomet Spine (Aka Ebi, LLC)·cleared 2014-11-05
K080646 — C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEMBiomet Spine·cleared 2008-05-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.