Recall Z-1464-2018 ยท EMO Knife, Periodontic
Ace Surgical Supply Co., Inc.
Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.
| Date | Mar 28, 2018 |
| Status | Terminated |
| Reason | The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade. |
| Root cause | Error in labeling |
| Action | ACE is contacting the 5 affected customers via certified mail for US customers and via email for non-US Customers. Follow-up notifications will be sent 12 weeks after initial notification. Firm will rework incorrectly packaged product and will use completed reply forms as effectiveness check. For further questions, please call (508) 588-3100. |
| Quantity | 6 |
| Distribution | US Distribution to the states of : MI, CA, OK, and Internationally to China, Canada, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.