Class 2 Device Recall Genesis Surgical Cassette Tapered

• Date Initiated by Firm: March 13, 2018
• Create Date: April 24, 2018
• Recall Status: Terminated 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/ Manufacturer: Keystone Dental Inc; 154 Middlesex Tpke; Burlington MA 01803-4403
• For Additional Information Contact: 866-902-9272
• 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: 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