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U.S. Department of Health and Human Services

Class 2 Device Recall 4 0 MM X 14 MM Variable Screw CTek Maxan Anterior Cervical Plate System.

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  Class 2 Device Recall 4 0 MM X 14 MM Variable Screw CTek Maxan Anterior Cervical Plate System. see related information
Date Initiated by Firm August 05, 2015
Date Posted September 09, 2015
Recall Status1 Terminated 3 on February 10, 2016
Recall Number Z-2744-2015
Recall Event ID 71940
510(K)Number K080646  
Product Classification Appliance, fixation, spinal intervertebral body - Product Code KWQ
Product Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.
Code Information Model Number 14-521614B, lot number 375440.
Recalling Firm/
Manufacturer		 Biomet Spine, LLC
310 Interlocken Pkwy Ste 120
Broomfield CO 80021-3464
For Additional Information Contact
303-443-7500
Manufacturer Reason
for Recall		 Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440.
FDA Determined
Cause 2		 Labeling mix-ups
Action Zimmer Biomet sent an Urgent Medical Device Recall Notice dated August 5, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by customer. Customers were instructed to immediately locate and discontinue use of the affected product. This action requires the immediate location and discontinued use of the item and its immediate return to Zimmer Biomet Spine. Specifically, customers were REQUIRED to take the following steps: " Immediately locate and remove from circulation the items consigned/loaned to your account as identified on page two of this notice. " Carefully follow the instructions on the enclosed "Response Form". " If you have further distributed these items to medical facilities, you MUST notify them of this action. This letter MUST be given to the person responsible for receiving recall notices. However, you are charged with the location and return of these items. Health care professionals and consumers may report serious adverse events or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone: Online: Fax: Phone: Regular Mail: www. fda .gov /MedWatch/report.htm (800) FDA-0178 (800} FDA-1088 Use postage-paid FDA form 3500 available at www.fda.gov/Medwatch/getforms.htm and mail to Medwatch, 5600 Fishers Lane, Rockville, MD 20852-9787. Questions related to this notice should be directed to 303-501-8400 Monday through Friday, 8 a.m.to 5 p.m. MST. Zimmer Blomet
Quantity in Commerce 7 parts
Distribution Nationwide Distribution including Distributed nationwide to OH, LA, TX, and GA.
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
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