Device Recall Bondek Sutures

  • Model / Serial
    Bondek, BON GN BR 0 GR19 1N7 USAB, Catalog #0500197-2, Lot numbers: 3244075;  Bondek, BON GN BR 2-0 GRB 121N7"USAB, Catalog #0520127-2, Lot #2361002; Bondek, BON GNBR 3-0 DR17 1N7"USAB, Catalog #0530177-2, Lot #2401863 & 2498856;  Bondek, BON GN BR 2-0 C-2/CST-4336, Catalog #833-136, Lot #2443985 & 3080258;  Bondek, BON GN BR 0 TC-43 2N 48, Catalog #833-213, Lot #2528539, & 3163971;  Bondek, BON GN BR 2-0 HS 36 1N27, Catalog # B2098G, Lot #2554480.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany
  • Product Description
    Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture: Bondek, BON GN BR 0 GR19 1N7 USAB, Catalog #0500197-2, Bondek, BON GN BR 2-0 GRB 121N7"USAB, Catalog #0520127-2, Bondek, BON GNBR 3-0 DR17 1N7"USAB, Catalog #0530177-2, Bondek, BON GN BR 2-0 C-2/CST-4336, Catalog #833-136,Bondek, BON GN BR 0 TC-43 2N 48, Catalog #833-213, Bondek, BON GN BR 2-0 HS 36 1N27, Catalog # B2098G
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Teleflex Creek Dr, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Bondek¿, TOPS ASSY P/P SLING, Catalog #84414323, Lot #9591.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany
  • Product Description
    Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture- Bondek¿, TOPS ASSY P/P SLING, Catalog #84414323
  • Manufacturer
  • Model / Serial
    Bondek, BON+ VI BR 3-0 2X70CM, Catalog # EP0242P, Lot #3328445;  Bondek, BON+ VI BR 3-0 HR30+ 1N70CM, Catalog # EP1054XP, Lot #3313774 & 3200044;  Bondek, BON+ VI BR 0 HR36+ 1N70CM, Catalog # EP1063XP, Lot #2297080 & 2467234;  Bondek, BON+ VI BR 2 HRX27 1N90CM, Catalog # EP1094P, Lot #2486461;  Bondek, BON+ VI BR 4-0 HRT17 1N70CM, Catalog # EP1100P, Lot #2351154;  Bondek, BON+ VI BR 3-0 HRT17 1N70CM, Catalog #EP1101P, Lot #2351154;  Bondek, BON+ VI BR 1 HRX48 1N90CM, Catalog #EP2057P, Lot #2306894 & 3308136;  Bondek, BON+ VI BR 2 HRX48 1N90CM, Catalog #EP2058P, Lot #2324039;  Bondek, BON+ VI BR 1 HS36 1N70CM, Catalog #EP3000P, Lot #2262121 & 2306894;  Bondek, BON+ VI BR 4-0 DS18 1N45CM, Catalog #EP4010P, Lot #2306897;  Bondek, BON+ VI BR 3-0 DS18 1N45CM, Catalog #EP4011P, Lot #3211901& 3346174;  Bondek, BON+ VI BR 4-0 DS18 1N70CM, Catalog # EP4013P, Lot #2306899 & 2306900;  Bondek, BON+ VI BR 3-0 HR26+ 1RN8X45CM, Catalog # EP8029XP, Lot #3335219; Bondek, BON+ VI BR 3-0 6X45CM, Catalog # EP8554P, Lot #3335220.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany
  • Product Description
    Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture--Bondek, BON+ VI BR 3-0 2X70CM, Catalog # EP0242P,Bondek, BON+ VI BR 3-0 HR30+ 1N70CM, Catalog # EP1054XP, Bondek, BON+ VI BR 0 HR36+ 1N70CM, Catalog # EP1063XP, Bondek, BON+ VI BR 2 HRX27 1N90CM, Catalog # EP1094P, Bondek, BON+ VI BR 4-0 HRT17 1N70CM, Catalog # EP1100P,Bondek, BON+ VI BR 3-0 HRT17 1N70CM, Catalog #EP1101P, Bondek, BON+ VI BR 1 HRX48 1N90CM, Catalog #EP2057P, Bondek, BON+ VI BR 2 HRX48 1N90CM, Catalog #EP2058P,Bondek, BON+ VI BR 1 HS36 1N70CM, Catalog #EP3000P, Bondek, BON+ VI BR 4-0 DS18 1N45CM, Catalog #EP4010P, Bondek, BON+ VI BR 3-0 DS18 1N45CM, Catalog #EP4011P, Bondek, BON+ VI BR 4-0 DS18 1N70CM, Catalog # EP4013P, Bondek, BON+ VI BR 3-0 HR26+ 1RN8X45CM, Catalog # EP8029XP, Bondek, BON+ VI BR 3-0 6X45CM, Catalog # EP8554P
  • Manufacturer