Device recall

Z-0718-2018: Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog…

FDA device recall · Class II · Keystone Dental Inc

Key facts

Recall number (Z-number) Z-0718-2018
Recall event 79066
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.
Product code DZE
Recalling firm Keystone Dental Inc
Recall class Class II
Status Terminated
Termination date Apr 16, 2019
510(k) numbers K071161
FEI number 3005990499

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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