Medical device recalls Moderate risk

Orthosoft, Inc. dba Zimmer CAS recalls SmartTools Knee System Orthopedic Stereotaxic Instrument

Recall date
February 20, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1868-2017
FDA classification
Class II
Brand / firm
Orthosoft, Inc. dba Zimmer CAS
Sold / distributed
Nationwide Distribution

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SmartTools Knee System Orthopedic Stereotaxic Instrument

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