Device recall

Z-0891-2017: Optimus Fixed Awl

FDA device recall · Class II · Amendia, Inc

Key facts

Recall number (Z-number) Z-0891-2017
Recall event 75856
Product Optimus Fixed Awl
Product code OVD
Recalling firm Amendia, Inc
Recall class Class II
Status Terminated
Termination date Feb 28, 2017
510(k) numbers K132596
FEI number 3007970248

At a glance

  • 1–9 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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