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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:123525

NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts.

Official recall number

Z-0463-2014

Evidence summary

Product code
HWT
Recall status
Terminated
Event initiated
November 19, 2013
Root cause
Labeling design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0463-2014

Field note

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