LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
Reported: December 17, 2014 Initiated: November 4, 2014 #Z-0590-2015
Product Description
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
Reason for Recall
The stem taper on this device is undersized; the gauge point is not deep enough.
Details
- Recalling Firm
- Smith & Nephew, Inc.
- Units Affected
- 45 units
- Distribution
- 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.
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.. Recalled by Smith & Nephew, Inc.. Units affected: 45 units.
Why was this product recalled? ▼
The stem taper on this device is undersized; the gauge point is not deep enough.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 17, 2014. Severity: Moderate. Recall number: Z-0590-2015.
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