Device recall

Z-1494-2021: Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into…

FDA device recall · Class II · Coltene Whaledent Inc

Key facts

Recall number (Z-number) Z-1494-2021
Recall event 87645
Product Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation. Model number/Catalog number: L741
Product code EBL
Recalling firm Coltene Whaledent Inc
Recall class Class II
Status Open, Classified
FEI number 2416455

At a glance

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