Recall Z-1805-2010 ยท LYC Bone Grafting Material, Synthetic
Ace Surgical Supply Co., Inc.
Calcium Sulfate Hemihydrate 0.5 gram kits.
| Date | Jun 16, 2010 (initiated May 14, 2010) |
| Status | Terminated |
| 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. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051381 | ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE Ace Surgical Supply Co., Inc., Jul 15, 2005 |