FDAClass IISeptember 1, 2021

AUGMENT Injectable Kit recall

AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343

Why was AUGMENT Injectable Kit recalled?

The kit contains the wrong vial tray in the package.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number K30003010, Lot 1706343

Product
AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343
Recalling firm
BioMimetic Therapeutics, LLC
Quantity
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.
Recall date
September 1, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls