ZimVie US Corp, LLC
FDA Regulatory Profile
ZimVie US Corp, LLC has 0 FDA recalls, 6 inspections, 1 510(k) clearance and 0 compliance actions on record.
- Latest inspection
- Jul 11, 2017 · NAI
- Latest 510(k)
- Sep 21, 2026
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 6 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Jul 11, 2017 | Palm Beach Gardens, FL | Devices | No Action Indicated (NAI) | 1038806 |
| Aug 6, 2014 | Palm Beach Gardens, FL | Devices | Voluntary Action Indicated (VAI) | 1038806 |
| May 14, 2014 | Palm Beach Gardens, FL | Devices | No Action Indicated (NAI) | 1038806 |
| Aug 2, 2013 | Palm Beach Gardens, FL | Devices | Official Action Indicated (OAI) | 1038806 |
| Jun 15, 2012 | Palm Beach Gardens, FL | Devices | Voluntary Action Indicated (VAI) | 1038806 |
| May 1, 2009 | Palm Beach Gardens, FL | Devices | Voluntary Action Indicated (VAI) | 1038806 |
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 1038806 | Palm Beach Gardens, FL | 6 | Jul 11, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260940 | BellaTek Bars | Sep 21, 2026 |