Recall Z-2219-2019 ยท FWM Prosthesis, Breast, Inflatable, Internal, Saline
Ideal Implant Incorporated
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.
| Date | Mar 18, 2019 |
| Status | Terminated |
| Reason | The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.