“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
Descripción del producto
Syneture Ti-Cron 0 BLUE 6X18" PRE-CUT || non-absorbable polyester sutures || Material 8886300162 || Ti-Cron is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neurological procedures
Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
Descripción del producto
Syneture Ti-Cron 0 5X18" BLUE T-19/GS-22 D-TACH || non-absorbable polyester sutures || Material 8886325962 || Ti-Cron is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neurological procedures
Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
Descripción del producto
Syneture Ti-Cron 1 Blue 5x18 HGS-22 D-Tach || non-absorbable polyester sutures || Material 8886326062 || Ti-Cron is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neurological procedures
Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
Descripción del producto
Syneture Ti-Cron 1 Blue 5x18 HGS-22 D-Tach || non-absorbable polyester sutures || Material 8886337272 || Ti-Cron is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neurological procedures