Device recall

Z-0603-2018: Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool

FDA device recall · Class II · Exactech, Inc.

Key facts

Recall number (Z-number) Z-0603-2018
Recall event 78064
Product Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
Product code OLO
Recalling firm Exactech, Inc.
Recall class Class II
Status Terminated
Termination date Apr 22, 2021
510(k) numbers K162567
FEI number 1038671

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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