Recall Z-1464-2018— Ace Surgical Supply Co., Inc.
Class II · Terminated
Class II FDA medical device recall by Ace Surgical Supply Co., Inc., initiated 2018-03-28, terminated 2018-09-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.. Reason: The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade..
- Recalling firm
- Ace Surgical Supply Co., Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-28
- Terminated
- 2018-09-11
- Firm location
- Brockton, MA, United States
Product description
Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.
Reason for recall
The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade.
Data sourced from openFDA. This site is unofficial and independent of the FDA.