Z-2219-2019Class II

IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc...

Name: Z-2219-2019 IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc...
Creator: Ideal Implant Incorporated
Published: 2019-03-18
License: https://open.fda.gov/license/

Ideal Implant Incorporated / initiated 2019-03-18 / Terminated / root cause: manufacturing process

FDA source

Ideal Implant Incorporated began a recall of IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 440cc, 475cc, 515cc... on 2019-03-18. FDA classified it as Class II and gives the reason as "The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2219-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-18
Posted: 2019-08-08
Terminated: 2021-03-03
Recalling firm: Ideal Implant Incorporated
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.
Product code: FWM Prosthesis, Breast, Inflatable, Internal, Saline
Reason for recall: The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recall was initiated via telephone and email on 3/18/2019 to one consignee and via email on 3/22/2019 to the other consignees and requested return of the implants.
Quantity in commerce: 1,704 implants
Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, ND, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. Country of Canada.
Product codes and lots: Serial numbers between 0100292 and 0102777.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2219-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2219-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-08

Product code FWM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)