FDAFDA · Food and drugs·Recall number Z-0591-2015
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
Published December 17, 2014 · Recall initiated: November 4, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The stem taper on this device is undersized; the gauge point is not deep enough.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Smith & Nephew, Inc.
- Distributor
- Worldwide Distribution: US (nationwide) including states of: MI, MN, MO, OH, PA, IA, and TN; and Internationally to: SWITZERLAND; CANADA, COLOMBIA, GERMANY, Dubai, (UAE), THAILAND; SOUTH AFRICA, SOUTH KOREA; and SINGAPORE.
- Lot
- Lot Number 14EM23391
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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