BioMimetic Therapeutics, LLC
FDA Regulatory Profile
BioMimetic Therapeutics, LLC has 1 FDA recall, 9 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-2335-2021 · Class II · Jul 23, 2021
- Latest inspection
- Aug 13, 2025 · NAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 1 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 9 | Nov 10, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2335-2021 | Class II | AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343 | Jul 23, 2021 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Aug 13, 2025 | Franklin, TN | Drugs | No Action Indicated (NAI) | 3003897776 |
| Oct 23, 2017 | Franklin, TN | Devices | Voluntary Action Indicated (VAI) | 3003897776 |
| Apr 13, 2017 | Franklin, TN | Devices | No Action Indicated (NAI) | 3003897776 |
| Jan 20, 2017 | Franklin, TN | Devices | No Action Indicated (NAI) | 3003897776 |
| Mar 3, 2016 | Franklin, TN | Devices | No Action Indicated (NAI) | 3003897776 |
| Sep 9, 2013 | Franklin, TN | Devices | No Action Indicated (NAI) | 3003897776 |
| Jul 18, 2013 | Franklin, TN | Devices | Voluntary Action Indicated (VAI) | 3003897776 |
| Apr 19, 2010 | Franklin, TN | Devices | No Action Indicated (NAI) | 3003897776 |
| Jan 27, 2009 | Franklin, TN | Devices | No Action Indicated (NAI) | 3003897776 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3003897776 | Franklin, TN | 9 | Aug 13, 2025 |