Device recall

Z-3018-2017: Truliant Tibial Trial Handle. To assist the surgeon in the implantation of…

FDA device recall · Class II · Exactech, Inc.

Key facts

Recall number (Z-number) Z-3018-2017
Recall event 77592
Product Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components according to a conventional technique for total knee replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.t Tibial Trial Handle
Product code MDM
Recalling firm Exactech, Inc.
Recall class Class II
Status Terminated
Termination date Nov 30, 2020
FEI number 1038671

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

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