Events

Recall of Device Recall Calcium Sulfate Hemihydrate

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ace Surgical Supply Co., Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55698
  • Event Risk Class
    Class 2
  • Event Number
    Z-1806-2010
  • Event Initiated Date
    2010-05-14
  • Event Date Posted
    2010-06-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91599
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bone grafting material, synthetic - Product Code LYC
  • Reason
    Fast set 4% potassium sulfate solution may not be sterile. for customers who have used the calcium sulfate hemihydrate kit without the fast set solution, then these potential risks identified do not apply. risks of adverse health consequences with the fast set 4% potassium sulfate solution include tissue inflammation and infection.
  • Action
    Ace Surgical has become aware through internal review of possibility sterility issues with one of the components included in the Calcium Hemihydrate 0.5 and 1.0 gram kits. Customers with questions should contact ACE Surgical using the recall hot line at (800) 441-3100 Ext. 204.

Device

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.

Manufacturer

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