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Recall Observatory FDA recall evidence

Derived label

Device software or design

ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 18033509855948

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
does not correspond to the intended design
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Orthofix Srl

Field note

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