| Class 2 Device Recall Max Implant System |  |
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
|
|
|
|