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U.S. Department of Health and Human Services

Class 2 Device Recall IDEAL IMPLANT Structured Breast Implant

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  Class 2 Device Recall IDEAL IMPLANT Structured Breast Implant see related information
Date Initiated by Firm March 18, 2019
Create Date August 08, 2019
Recall Status1 Terminated 3 on March 03, 2021
Recall Number Z-2219-2019
Recall Event ID 83251
PMA Number P120011 
Product Classification Prosthesis, breast, inflatable, internal, saline - Product Code FWM
Product 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.
Code Information Serial numbers between 0100292 and 0102777.
Recalling Firm/
Manufacturer		 Ideal Implant Incorporated
14881 Quorum Dr Ste 925
Dallas TX 75254-7132
For Additional Information Contact Robert S. Hamas, MD
214-492-2500
Manufacturer Reason
for Recall		 The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = FWM and Original Applicant = Bimini Health Tech
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