Date: May 27, 2010
Dear Valued ACE Surgical Customer:
This is an update to the Urgent Customer Notification you may have already received. ACE Surgical Supply is voluntarily recalling Calcium Sulfate Hemihydrate 1.0 gram and 0.5 gram kits. The recall was originally initiated because we became aware of a possible sterility issue with one of the components included in the Calcium Sulfate Hemihydrate 0.5 and 1.0 gram kits. The kits are provided with a Regular Set 0.9% NaCl (Saline) solution and a Fast Set 4% potassium sulfate solution. Evidence suggests that the Fast Set solution (4% potassium sulfate) may contain Burkholderia multivorans, a pathogenic bacteria. B. multivorans is an opportunistic pathogen in compromised individuals particularly those with cystic fibrosis or chronic granulomataous disease. Symptoms include high fever, bacteriemia, serious infection and other serious health consequences. Since the original customer notification, ACE Surgical has received reports from dental practitioners of adverse events from grafting procedures. Symptoms have included: infection, pain, graft failure and severe inflammation,
The Calcium Sulfate Hemihydrate powder and 0.9% NaCl solution components have been provided sterile and if you have used the Calcium Sulfate Hemihydrate kit without the Fast Set solution then the potential risks identified above do not apply.
Lots affected by the recall have been distributed from 05/05/2008 to 05/05/2010. Lot numbers are provided below for your reference:
Calcium Sulfate Hemihydrate 1.0 gram Product Code #5052001
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
Calcium Sulfate Hemihydrate 0.5 gram Product Code #5052002
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
Please immediately cease use of the Calcium Sulfate Hemihydrate product since use of the fast set solution product may cause serious infections in patients with compromised immune systems particularly individuals with cystic fibrosis. There is also a potential risk of local adverse tissue reaction – inflammation, infection to injured tissues (bone, periodontal or mucosal tissues) and systemic adverse tissue reaction from use of the Fast Set 4% potassium sulfate component.
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As a result of the recall, we request that you take the actions described below even if you have used the Calcium Sulfate product without the Fast Set 4% potassium sulfate solution:
1. Complete and return the recall reply form enclosed.
2. If applicable, forward a listing of any customers you redistributed the product to:
ACE SURGICAL SUPPLY CO.
ATTN: QA
1034 Pearl St.
BROCKTON, MA 02301
If you have already responded to a previous customer notification by providing ACE Surgical your customer response form then no further action is required.
ACE Surgical will send you arrangements to return product subject to the recall back to our facility. Upon return, credit will be issued to your account and replacement product will be available.
We appreciate your assistance with this matter and apologize for any inconvenience. If you have questions regarding this communication or if your patients develop any adverse events please notify ACE Surgical using the recall hot line at (800) 441-3100 Ext. 204.
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