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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:128824

PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to organize, store and protect its contents from damage consistent with typical hospital or surgical center circulation (i.e. between central services and the operating room) and during transport between a Zimmer distributorship and a health care facility by Zimmer distributorship personnel.

Official recall number

Z-2288-2014

Evidence summary

Product code
FSM
Recall status
Terminated
Event initiated
July 01, 2014
Root cause
Device Design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2288-2014

Field note

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