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U.S. Department of Health and Human Services

Class 2 Device Recall AUGMENT Injectable

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  Class 2 Device Recall AUGMENT Injectable see related information
Date Initiated by Firm July 23, 2021
Create Date August 23, 2021
Recall Status1 Completed
Recall Number Z-2335-2021
Recall Event ID 88395
PMA Number P100006 
Product Classification Filler, bone void, synthetic peptide - Product Code NOX
Product AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343
Code Information Model Number K30003010, Lot 1706343
Recalling Firm/
Manufacturer		 BioMimetic Therapeutics, LLC
389 Nichol Mill Ln # A
Franklin TN 37067-4882
For Additional Information Contact Meghan Wells
615-844-1280
Manufacturer Reason
for Recall		 The kit contains the wrong vial tray in the package.
FDA Determined
Cause 2		 Packaging process control
Action Recall communication was sent out via FedEx Priority Overnight. Customers are instructed to immediately quarantine all recalled products they have and return all affected product to the recalling firm's Arlington, TN Warehouse as soon as possible. If they have further distributed the affected product, they are instructed to notify the applicable parties at once about this recall. They may copy and distribute the notification letter and the recalling firm will work directly with them to collect the recalled items.
Quantity in Commerce 499 units
Distribution US Nationwide distribution in the states of AK, CA, CO, FL, GA, IA, ID, IL, IN, MA, MI, MN, NC, NJ, NM, NY, OH, OR, PA, TX, UT, VA, WA, and WI.
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.
PMA Database PMAs with Product Code = NOX and Original Applicant = BIOMIMETIC THERAPEUTICS,LLC
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