Reported Apr 26, 2017 · Terminated

SmartTools Knee System Orthopedic Stereotaxic Instrument

Orthosoft, Inc. dba Zimmer CAS

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: Orthosoft, Inc. dba Zimmer CAS · 75 Queen St #3300 · Montreal, N/A · N/A

Is this the product you have?

  • SmartTools Knee System Orthopedic Stereotaxic Instrument
Lot codes and dates
  • Lots
    • 130542A1
    • 1405941
    • 140146
    • 140146-1
    • 140147
    • 140407A
    • 140407A-1
    • 140407B
    • 140407-B-1
    • 140860
    • 140860-1
    • 141035
    • 150120
    • B150120
    • B150711
Amount recalled
84

Where it was sold

  • Nationwide

Why it was recalled

There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P

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 Sep 18, 2017 · Data as of Sep 19, 6:06 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.