IDEAL IMPLANT Structured Breast Implant — Class II medical device recall Z-2219-2019
Terminated recall by Ideal Implant Incorporated, reported 2019-08-14, distributed nationwide. The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly afte
| Recall number | Z-2219-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ideal Implant Incorporated, Dallas, TX, United States |
| Recall initiated | 2019-03-18 |
| Classified | 2019-08-08 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2021-03-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,704 implants |
| Reason classes | packaging |
Product
IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 440cc, 475cc, 515cc, 555cc, 595cc, 635cc, and 675cc.
Reason for recall
The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2219-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.