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.
This recall has been terminated (originally issued March 18, 2019).
- Company
- Ideal Implant Incorporated
- Recall Initiated
- March 18, 2019
- Terminated
- March 3, 2021
- Recall Number
- Z-2219-2019
- Quantity
- 1,704 implants
- Firm Location
- Dallas, TX
- Official Source
- View on FDA website ↗
Reason for Recall
The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation.
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.
Lot / Code Info
Serial numbers between 0100292 and 0102777.
Root Cause
Process control
Action Taken
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.