Z-2219-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2019
- Initiation Date
- March 18, 2019
- Termination Date
- March 3, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,704 implants
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.
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.
Code Information
Serial numbers between 0100292 and 0102777.