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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 Injectablesee related information
Date Initiated by FirmJuly 23, 2021
Create DateAugust 23, 2021
Recall Status1 Terminated 3 on September 04, 2024
Recall NumberZ-2335-2021
Recall Event ID 88395
PMA NumberP100006 
Product Classification Filler, bone void, synthetic peptide - Product Code NOX
ProductAUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343
Code Information Model Number K30003010, Lot 1706343
FEI Number 3003897776
Recalling Firm/
Manufacturer		 BioMimetic Therapeutics, LLC
389 Nichol Mill Ln # A
Franklin TN 37067-4882
For Additional Information ContactMeghan 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
ActionRecall 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 Commerce499 units
DistributionUS 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 CycleTPLC 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.
PMA DatabasePMAs with Product Code = NOX
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