Device recall

Z-1062-2019: Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical…

FDA device recall · Class II · Keystone Dental Inc

Key facts

Recall number (Z-number) Z-1062-2019
Recall event 82374
Product Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 30-70021
Product code DZE
Recalling firm Keystone Dental Inc
Recall class Class II
Status Terminated
Termination date Jun 19, 2020
510(k) numbers K112795
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

Browse all FDA device recalls (products)