FDA Medical Device Recalls (openFDA)
BioMimetic Therapeutics, LLC: AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343
- Recall number
- Z-2335-2021
- Recalling firm
- BioMimetic Therapeutics, LLC
- Product
- AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343
- Status
- Terminated
- Initiated
- 2021-07-23
- Posted
- not on file
- Terminated
- 2024-09-04
- Reason
- The kit contains the wrong vial tray in the package.
- 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
- 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.
- Lot, serial or model codes
- Model Number K30003010, Lot 1706343
- 510(k) numbers
- not on file
- PMA numbers
- ["P100006"]
- Product code
- NOX
- Firm FEI
- 3003897776
- Firm city
- Franklin
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28