Recall Z-2219-2019— Ideal Implant Incorporated

Name: FDA recall Z-2219-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-18

Class II · Terminated

Class II FDA medical device recall by Ideal Implant Incorporated, initiated 2019-03-18, terminated 2021-03-03. FDA's recall record names no specific 510(k) clearance for this event. 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..

Recalling firm: Ideal Implant Incorporated
Classification: Class II
Status: Terminated
Initiated: 2019-03-18
Terminated: 2021-03-03
Firm location: Dallas, TX, United States

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.