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Class 2 Device Recall Calcium Sulfate Hemihydrate |
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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
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Product Classification |
Bone grafting material, synthetic - Product Code LYC
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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/ Manufacturer |
Ace Surgical Supply Co., Inc. 1034 Pearl St Brockton MA 02301
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For Additional Information Contact |
508-588-3100
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = LYC and Original Applicant = ACE SURGICAL SUPPLY CO., INC.
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