Device recall

Z-1619-2012: Tibial Alignment Handle Triathlon Instruments CAT #: 6541-2-807 Nav Tibial…

FDA device recall · Class II · Stryker Howmedica Osteonics Corp.

Key facts

Recall number (Z-number) Z-1619-2012
Recall event 61343
Product Tibial Alignment Handle Triathlon Instruments CAT #: 6541-2-807 Nav Tibial Alignment Handle Triathlon Instruments CAT #; 6541-2-808 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 The tibial alignment handles Cat# 6451-2-807 and 6541-2-808 are part of the Triathlon Knee Instruments…
Product code LXH
Recalling firm Stryker Howmedica Osteonics Corp.
Recall class Class II
Status Terminated
Termination date Sep 10, 2014
FEI number 3003070421

At a glance

  • None 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

Browse all FDA device recalls (products)