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U.S. Department of Health and Human Services

Class 2 Device Recall Calcium Sulfate Hemihydrate

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  Class 2 Device Recall Calcium Sulfate Hemihydrate see related information
Date Initiated by Firm May 14, 2010
Date Posted June 16, 2010
Recall Status1 Terminated 3 on February 02, 2012
Recall Number Z-1805-2010
Recall Event ID 55698
510(K)Number K051381  
Product Classification Bone grafting material, synthetic - Product Code LYC
Product Calcium Sulfate Hemihydrate 0.5 gram kits.
Code Information 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 
Recalling Firm/
Ace Surgical Supply Co., Inc.
1034 Pearl St
Brockton MA 02301
For Additional Information Contact
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Process control
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.
Quantity in Commerce 4133
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LYC and Original Applicant = ACE SURGICAL SUPPLY CO., INC.