Devices

Device Recall Calcium Sulfate Hemihydrate

  • Model / Serial
    Calcium Sulfate Hemihydrate 0.5 gram Product Code #5052002  lot numbers  08030107, 08040061, 08050021, 08080027, 08100091, 08120045, 09010054, 09020040, 09020043, 09030046, 09040018, 09050032,09060094, 09070045, 09090002, 09100001, 09100067, 09120012, 10010008, 10010068, 10010069, 10020065, 10030002, 10030059, 10030061, 10040012
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Class 2 recall - Worldwide distribution . Item Number 505-2001: South Africa, Australia, Vietnam, Ontario, Canada, Italy, Lebanon, Petaling Jaya, Malaysia, Portugal, and West Indies. Item Number 505-2002: Australia, Bermuda, Canada, Lebanon, Petaling Jaya, Malaysia, and Portugal.
  • Product Description
    Calcium Sulfate Hemihydrate 0.5 gram kits.
  • Manufacturer
    Ace Surgical Supply Co., Inc.
  • 1 Event

Manufacturer

Ace Surgical Supply Co., Inc.
  • Manufacturer Address
    Ace Surgical Supply Co., Inc., 1034 Pearl St, Brockton MA 02301
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall Calcium Sulfate Hemihydrate
  • Model / Serial
    Calcium Sulfate Hemihydrate 1.0 gram Product Code #5052001  lot numbers: 08030106, 08030030, 08040035, 08050025, 08070036, 08090049, 08100092, 08110041, 08120097, 09010055, 09020041, 09030047, 09040017, 09050004, 09060013, 09060095, 09070046, 09080033, 09090026, 09100002, 09100066, 09120011, 09120070, 10010007, 10010067, 10020064, 10030003, 10030060, 10040011, 10040046
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Class 2 recall - Worldwide distribution . Item Number 505-2001: South Africa, Australia, Vietnam, Ontario, Canada, Italy, Lebanon, Petaling Jaya, Malaysia, Portugal, and West Indies. Item Number 505-2002: Australia, Bermuda, Canada, Lebanon, Petaling Jaya, Malaysia, and Portugal.
  • Product Description
    Calcium Sulfate Hemihydrate 1.0 gram kits.
  • Manufacturer
    Ace Surgical Supply Co., Inc.