Device product
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
Z-0589-2015
Product summary
- Event
- Event 69759
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24 units
- Official record key
device-enforcement:Z-0589-2015
Official wording
Reason: The stem taper on this device is undersized; the gauge point is not deep enough.
Code information: Lot Number 14FM05730
Distribution pattern: 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.
Derived failure modes
-
Unknown
The stem taper on this device is undersized; the gauge point is not deep enough.