Device Recall Straumann Emdogain

  • Model / Serial
    Lot MZ538, Syringe Blister Lot MG253B, Exp 9/4/2018 Lot NJ580, Syringe Blister Lot MG253B, Exp 9/30/2018 Lot NK215, Syringe Blister Lot NE101A, Exp 3/31/2019 Lot NP343, Syringe Blister Lot NE101A, Exp 3/31/2019
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Distributed US Nationwide and Puerto Rico.
  • Product Description
    Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.113
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Straumann Manufacturing, Inc., 60 Minuteman Rd, Andover MA 01810-1008
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

5 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot NY938, Syringe Blister Lot MN843, Exp 11/30/2018 Lot NP738, Syringe Blister Lot NE101A, Exp 3/31/2019 Lot PG629, Syringe Blister Lot NK216, Exp 5/31/2019 Lot PY817, Syringe Blister Lot PT888C, Exp 1/31/2020
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Distributed US Nationwide and Puerto Rico.
  • Product Description
    Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114W
  • Manufacturer
  • Model / Serial
    Lot NP737, Syringe Blister Lot NA438A, Exp 3/31/2019; Lot PG628, Syringe Blister Lot NF819A, Exp 3/31/2019; Lot PY816, Syringe Blister Lot PT888C, Exp 1/31/2020; Lot NY939, Syringe Blister Lot, NA438A, Exp 3/31/2019
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Distributed US Nationwide and Puerto Rico.
  • Product Description
    Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W
  • Manufacturer
  • Model / Serial
    Lot LT830, Syringe Blister Lot LK692B, Exp 5/31/2018 Lot LZ706, Syringe Blister Lot LK692B, Exp 5/31/2018 Lot MG929, Syringe Blister Lot LK692B, Exp 5/31/2018 Lot MT037, Syringe Blister Lot MG253A, Exp 9/30/2018 Lot MZ441, Syringe Blister Lot MG253A, Exp 9/30/2018 Lot NJ289, Syringe Blister Lot MG253A, Exp 9/30/2018 Lot NJ579, Syringe Blister Lot NA438A, Exp 3/31/2019 Lot NP340, Syringe Blister Lot NA438A, Exp 3/31/2019
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Distributed US Nationwide and Puerto Rico.
  • Product Description
    Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099
  • Manufacturer
  • Model / Serial
    Lot LZ713, Syringe Blaster Lot LP632B, Exp 6/30/2018 Lot MZ542, Syringe Blaster Lot LP632B, Exp 6/30/2018 Lot MG933, Syringe Blaster Lot LP632B, Exp 6/30/2018 Lot MZ543, Syringe Blaster Lot MG253C, Exp 9/30/2018 Lot NJ581, Syringe Blaster Lot MG253C, Exp 9/30/2018 Lot NJ582, Syringe Blaster Lot NA438B, Exp 3/31/2019 Lot NP345, Syringe Blaster Lot NE101B, Exp 3/31/2019
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Distributed US Nationwide and Puerto Rico.
  • Product Description
    Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115
  • Manufacturer
  • Model / Serial
    Lot NZ535, Syringe Blaster Lot LP632A, Exp 6/30/2018 Lot PG631, Syringe Blaster Lot MX842B, Exp 2/28/2019 Lot NP739, Syringe Blaster Lot NE101B, Exp 3/31/2019 Lot PY818, Syringe Blaster Lot PT888A, Exp 1/31/2020
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Distributed US Nationwide and Puerto Rico.
  • Product Description
    Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W
  • Manufacturer