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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:122068

GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic

Official recall number

Z-0445-2014

Evidence summary

Product code
JWH
Recall status
Terminated
Event initiated
August 27, 2013
Root cause
Package design/selection
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0445-2014

Field note

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