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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:131934

Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable instrument intended for use In multiple TKA procedures. The Persona Surgical Technique indicates that the Persona Cemented Tibial Broach Inserter/Extractor Handle is intended to broach the proximal tibia in preparation for the full seating of the tibial implant.

Official recall number

Z-0853-2015

Evidence summary

Product code
JWH
Recall status
Terminated
Event initiated
December 04, 2014
Root cause
Process design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0853-2015

Field note

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