Device recall

Z-1390-2019: Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article…

FDA device recall · Class II · Thommen Medical AG

Key facts

Recall number (Z-number) Z-1390-2019
Recall event 82675
Product Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapter for handpiece, guided reusable, for guide sleeve 4.8 mm is used to transfer the implant from the packaging to the patient via a plug-in connection and screwed in manually or…
Product code NDP
Recalling firm Thommen Medical AG
Recall class Class II
Status Terminated
Termination date Aug 12, 2019
FEI number 3003184527

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)