FDA Device

Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.

Hazard

The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade.

What You Should Do

Remedy

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.

Products

Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.
Brand
Ace Surgical Supply Co., Inc.
UPC
Lot # M050225

Units Affected

6