FDA Device recall Z-2219-2019
IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 44…
- FDA Device
- Class II
- terminated
- Published 2019-08-14
On 2019-08-14 the FDA classified a Class II recall of IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 44… by Ideal Implant, citing the implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2219-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-18 |
| Published | 2019-08-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ideal Implant |
| Distribution | US |
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
The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation.
Identifiers
| code_info | Serial numbers between 0100292 and 0102777. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2219-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.