Recall Z-2335-2021 ยท NOX Filler, Bone Void, Synthetic Peptide
BioMimetic Therapeutics, LLC
AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343
| Date | Jul 23, 2021 |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.