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Terminated

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.

FDA Recall Z-2219-2019 · Posted None

Recalling FirmIdeal Implant Incorporated
Recall StatusTerminated
Product CodeFWM
Date Initiated2019-03-18
Date Terminated2021-03-03
Product Quantity1,704 implants

Reason for Recall

The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation.

Firm 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.

Root Cause

Process control

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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