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U.S. Department of Health and Human Services

Class 2 Device Recall Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009

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  Class 2 Device Recall Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 see related information
Date Initiated by Firm March 28, 2018
Create Date April 20, 2018
Recall Status1 Terminated 3 on September 11, 2018
Recall Number Z-1464-2018
Recall Event ID 79798
Product Classification Knife, periodontic - Product Code EMO
Product Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009

Used to achieve epithelial graft in the oral cavity.
Code Information Lot # M050225
Recalling Firm/
Manufacturer		 Ace Surgical Supply Co., Inc.
1034 Pearl St
Brockton MA 02301-5411
For Additional Information Contact Kathy Strange
508-588-3100
Manufacturer Reason
for Recall		 The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade.
FDA Determined
Cause 2		 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 in Commerce 6
Distribution US Distribution to the states of : MI, CA, OK, and Internationally to China, Canada,
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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