Class 2 Device Recall MaxAn 4.0mm and 4.5mm fixed screw

• Date Initiated by Firm: September 29, 2015
• Date Posted: November 03, 2015
• Recall Status: Terminated on April 29, 2016
• Recall Number: Z-0203-2016
• Recall Event ID: 72312
• 510(K)Number: K080646 K133518
• Product Classification: appliance, fixation, spinal intervertebral body - Product Code KWQ
• 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.
• 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
• Recalling Firm/ Manufacturer: Biomet Spine, LLC; 310 Interlocken Pkwy Ste 120; Broomfield CO 80021-3464
• For Additional Information Contact: Mike Medina; 303-443-7500 Ext. 244
• Manufacturer Reason for Recall: The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.
• FDA Determined Cause: Labeling mix-ups
• Action: Zimmer Biomet Spine sent an Urgent Medical Device Recall Notice dated September 29, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If the device has already been implanted, written confirmation of this will be required and the necessary parties will be contacted. They will store returned product in quarantine in an isolated location until they can undergo inspection to verify if they are conforming or not and then will be destroyed or retained. Necessary parts will be destroyed so that it is visually obvious they are no longer functional. For further questions call (303) 443-7500 ext.244.
• Quantity in Commerce: 17 units
• Distribution: US Distribution to the states of : NY, MO, and FL
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KWQ; 510(K)s with Product Code = KWQ