Device Recall Syneture Surgilon

  • Model / Serial
    Lot Code Number:  D1C0332X D1C0373X D1B0679X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • Product Description
    Syneture Surgilon 0 Black 5X18 T-3/GS-23 D-TACH || non-absorbable braided nylon sutures || Material 8886199362 || Surgilon is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neural tissue.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Covidien LP, 60 Middletown Ave, North Haven CT 06473-3908
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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.
  • Source
    USFDA

8 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Code Number:  D1C0200G D1C0662GX
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • Product Description
    Syneture Sofsilk 2/0 30" BLACK V-20 DT || non-absorbable braided nylon sutures || GS66M || Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery
  • Manufacturer
  • Model / Serial
    Lot Code Number: D1C0077 D1C0274 D1A0463
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • Product Description
    Syneture Sofsilk 0 18" BLACK GS-21 DT || non-absorbable braided nylon sutures || CS10M || Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery
  • Manufacturer
  • Model / Serial
    Lot Code Number:  D1C0213
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • Product Description
    Syneture Sofsilk 3/0 BK 12X18" PRE-CUT WAX-RACE || non-absorbable braided nylon sutures || S194 || Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery
  • Manufacturer
  • Model / Serial
    Lot Code Number:  D1C0270
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • Product Description
    Syneture Sofsilk 0 BLACK 6X 18" PRE-CUT WAX/RACE || non-absorbable braided nylon sutures || S196 || Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery
  • Manufacturer
  • Model / Serial
    Lot Code Number:  D1D0288X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • Product Description
    Syneture Surgilon 5/0 Blk 5X18 T-37/CV-20 D-TACH || non-absorbable braided nylon sutures || Material 8886191022 || Surgilon is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neural tissue.
  • Manufacturer
3 more