Ideal Implant Incorporated
FDA Regulatory Profile
Ideal Implant Incorporated has 1 FDA recall, 5 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- Z-2219-2019 · Class II · Mar 18, 2019
- Latest inspection
- Jun 2, 2021 · NAI
Reviewing Ideal Implant Incorporated as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Check this supplier
Or check Ideal Implant Incorporated yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Get a free API key
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 | 5 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2219-2019 | Class II | IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc… | Mar 18, 2019 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Jun 2, 2021 | Dallas, TX | Devices | No Action Indicated (NAI) | 3008342021 |
| Feb 3, 2020 | Dallas, TX | Devices | Official Action Indicated (OAI) | 3008342021 |
| Feb 3, 2016 | Dallas, TX | Devices | Voluntary Action Indicated (VAI) | 3008342021 |
| Jul 20, 2012 | Dallas, TX | Devices | Voluntary Action Indicated (VAI) | 3008342021 |
| May 21, 2010 | Dallas, TX | Devices | Official Action Indicated (OAI) | 3008342021 |
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 3008342021 | Dallas, TX | 5 | Jun 2, 2021 |