Device recall

Z-0906-2015: Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3…

FDA device recall · Class II · Exactech, Inc.

Key facts

Recall number (Z-number) Z-0906-2015
Recall event 69466
Product Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants
Product code JWH
Recalling firm Exactech, Inc.
Recall class Class II
Status Terminated
Termination date Jun 8, 2016
510(k) numbers K033883
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

Browse all FDA device recalls (products)