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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall MaxAn 4.0mm and 4.5mm fixed screw see related information
Date Initiated by Firm September 29, 2015
Date Posted November 03, 2015
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = BIOMET SPINE
510(K)s with Product Code = KWQ and Original Applicant = BIOMET SPINE (AKA EBI, LLC)
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