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U.S. Department of Health and Human Services

Class 2 Device Recall Genesis Surgical Cassette Tapered

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  Class 2 Device Recall Genesis Surgical Cassette Tapered see related information
Date Initiated by Firm March 13, 2018
Create Date April 24, 2018
Recall Status1 Terminated 3 on July 23, 2018
Recall Number Z-1485-2018
Recall Event ID 79749
510(K)Number K101545  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Genesis Surgical Cassette Tapered

Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
Code Information lot #s 38177 38330 38421
Recalling Firm/
Keystone Dental Inc
154 Middlesex Tpke
Burlington MA 01803-4403
For Additional Information Contact
Manufacturer Reason
for Recall
The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette.
FDA Determined
Cause 2
Error in labeling
Action Notification was mailed to all impacted customers on March 13, 2018, via overnight Federal Ex-press. Customer Relations will contact the customers via phone to ensure the customers received the notification, instructions, and replacement grommets. Customer Relations Reply Forms are being used to document the communication. For further questions, please call (866) 902-9272.
Quantity in Commerce 19
Distribution USA (nationwide) Distribution and Internationally to Turkey.
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.
510(K) Database 510(K)s with Product Code = DZE and Original Applicant = KEYSTONE DENTAL