Reported Oct 13, 2021 · Terminated

ARCH Leg Positioning System

Innovative Orthopedic Technologies, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Innovative Orthopedic Technologies, LLC · 1115 Highway 124 · Winnie, TX · 77665

Is this the product you have?

  • ARCH Leg Positioning System
Lot codes and dates
  • Model6813010
  • Serial Numbers
    • 6813010.0066
    • 6813010.0067
    • 6813010.0069
    • 6813010.0070
    • 6813010.0071
    • 6813010.0072
    • 6813010.0073
    • 6813010.0074
    • 6813010.0075
    • 6813010.0076
Amount recalled
10 units

Where it was sold

Why it was recalled

Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 29, 2024 · Data as of Sep 19, 4:52 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.