Z-2335-2021Class II

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

Name: Z-2335-2021 AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343
Creator: BioMimetic Therapeutics, LLC
Published: 2021-07-23
License: https://open.fda.gov/license/

BioMimetic Therapeutics, LLC / initiated 2021-07-23 / Terminated / root cause: packaging

FDA source

BioMimetic Therapeutics, LLC began a recall of AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343 on 2021-07-23. FDA classified it as Class II and gives the reason as "The kit contains the wrong vial tray in the package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2335-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-23
Posted: 2021-08-23
Terminated: 2024-09-04
Recalling firm: BioMimetic Therapeutics, LLC
Product: AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343
Product code: NOX Filler, Bone Void, Synthetic Peptide
Reason for recall: The kit contains the wrong vial tray in the package.
Root cause tag: packaging
FDA root cause: 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.
Product codes and lots: Model Number K30003010, Lot 1706343

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2335-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2335-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-01	2021-08-23

Product code NOX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)