Device recall

Z-0943-2021: Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A

FDA device recall · Class II · The Binding Site Group, Ltd.

Key facts

Recall number (Z-number) Z-0943-2021
Recall event 86926
Product Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
Product code DFH
Recalling firm The Binding Site Group, Ltd.
Recall class Class II
Status Terminated
Termination date Dec 23, 2024
510(k) numbers K173732
FEI number 3002808340

At a glance

  • 1–9 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

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