Z-2219-2019 Class II Terminated
FDA device recall Z-2219-2019 was initiated by Ideal Implant Incorporated on March 18, 2019 and is designated Class II. Reason for recall: The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation. The recall status is terminated (terminated March 3, 2021). Affected quantity: 1,704 implants.
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.