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U.S. Department of Health and Human Services

Class 2 Device Recall Stage1 Tissue Punch

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  Class 2 Device Recall Stage1 Tissue Punch see related information
Date Initiated by Firm January 24, 2018
Create Date April 19, 2018
Recall Status1 Terminated 3 on July 30, 2018
Recall Number Z-1443-2018
Recall Event ID 79615
Product Classification Accessories, implant, dental, endosseous - Product Code NDP
Product Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K.

Intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
Code Information Lot numbers:  33434, expiration date: 2022-04; 33945, expiration date: 2022-05; 34294, expiration date: 2022-06; and  34987, expiration date: 2022-07.  
Recalling Firm/
Manufacturer		 Keystone Dental Inc
154 Middlesex Tpke
Burlington MA 01803-4403
For Additional Information Contact J'hanna Drzyzga
866-902-9272
Manufacturer Reason
for Recall		 The cutting edge of tissue punches may be potentially damaged with small dents and nicks.
FDA Determined
Cause 2		 Under Investigation by firm
Action An Urgent - Medical Device Recall letter, dated January 31, 2018, was sent to the impacted customers on 02/01/2018. The letter identified the affected device and the reason for the recall. Customers were instructed to immediately cease using the recalled product and return unused products to Keystone Dental. Customer Relations Reply Forms are being utilized to document the communication. Completed Relations Reply Forms should be faxed/ emailed to Customer Support; 866-903-9272 or customersupport@keystonedental.com.
Quantity in Commerce 101
Distribution Worldwide Distribution -- US, to the state of California; and, the countries of Canada and Germany
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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