Reported Feb 4, 2015 · Terminated

Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during…

Orthosensor, Inc.

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: Orthosensor, Inc. · 1560 Sawgrass Corporate Pkwy · Sunrise, FL · 33323-2858

Is this the product you have?

  • Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
Lot codes and dates
    • Model SYK-TRCR 02
    • Lot # 091914V11770
    • Serial #s: 411654008
    • 411585023
    • 411654007
    • 411585032
    • 411585014
    • 411654016
    • 411585017
    • 411654015
    • 411585030
    • 411654020
    • 411654004
    • 411654010
    • 411585007
    • 411585005
    • 411654011
    • 411585036
    • 411585035
    • 411654018
    • 411654012
    • 411585011
    • 411654014
    • 411654005
    • 411654001
    • 411585003
Amount recalled
22 devices

Where it was sold

Why it was recalled

Presence of one inoperable (dead) sensor pad.

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 Mar 13, 2015 · Data as of Sep 19, 5:27 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.