Recall Z-1806-2010
Ace Surgical Supply Co., Inc. · initiated May 14, 2010
Product
Calcium Sulfate Hemihydrate 1.0 gram kits.
Codes / lots: 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
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: Process control
Action taken
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.
Details
- Recall number
- Z-1806-2010
- Initiated
- May 14, 2010
- Posted by FDA
- June 16, 2010
- Terminated
- February 2, 2012
- Product code
- LYC – Bone Grafting Material, Synthetic
- Quantity
- 7930
- 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.
- Recalling firm
- Ace Surgical Supply Co., Inc., Brockton, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1805-2010 | Calcium Sulfate Hemihydrate 0.5 gram kits.Fast set 4% potassium sulfate solution may not be sterile. For customers who have used the Calcium Sulfate… | 05/14/2010Terminated |