Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.
FDA Recall Z-1464-2018 · Posted None
Recalling FirmAce Surgical Supply Co., Inc.
Recall StatusTerminated
Product CodeEMO
Date Initiated2018-03-28
Date Terminated2018-09-11
Product Quantity6
Reason for Recall
The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade.
Firm 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.
Root Cause
Error in labeling
Distribution Pattern
US Distribution to the states of : MI, CA, OK, and Internationally to China, Canada,
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.