Recall Z-0718-2018— Keystone Dental Inc

Name: FDA recall Z-0718-2018
Creator: U.S. Food and Drug Administration
Published: 2017-06-16

Class II · Terminated

Class II FDA medical device recall by Keystone Dental Inc, initiated 2017-06-16, terminated 2019-04-16. It names one FDA 510(k) clearance: K071161. 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.. Reason: An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label..

Recalling firm: Keystone Dental Inc
Classification: Class II
Status: Terminated
Initiated: 2017-06-16
Terminated: 2019-04-16
Firm location: Burlington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K071161 — ENDOSSEOUS DENTAL IMPLANT SYSTEMSouthern Implants, Inc.·cleared 2007-11-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.

Data sourced from openFDA. This site is unofficial and independent of the FDA.