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U.S. Department of Health and Human Services

Class 2 Device Recall Max Implant System

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  Class 2 Device Recall Max Implant System see related information
Date Initiated by Firm June 16, 2017
Create Date February 26, 2018
Recall Status1 Terminated 3 on April 16, 2019
Recall Number Z-0718-2018
Recall Event ID 79066
510(K)Number K071161  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7


Dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and overdentures in patients with partial or full edentulism of the upper or lower jaw.
Code Information Catalog Number D-TAP-MAX7-7, Lot 31444
Recalling Firm/
Manufacturer		 Keystone Dental Inc
154 Middlesex Tpke
Burlington MA 01803-4403
For Additional Information Contact Saba Shahid
781-328-3313
Manufacturer Reason
for Recall		 An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Consignees were initially called between June 13, 2017 and June 20, 2017. Customer Relations Fax Back forms were completed to document the phone calls. A notification letter was also sent via FedEx or hand-delivered on 6/19/17. All returned product will be scrapped. For further questions, please call (781) 328-3313.
Quantity in Commerce 72
Distribution USA (nationwide) Distribution to the states of : CA, CO, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NY, OH, PA, TN, TX, UT, VA, VT, WA, WI and WV; and Internationally to 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.
510(K) Database 510(K)s with Product Code = DZE and Original Applicant = SOUTHERN IMPLANTS, INC.
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