Derived label
Device software or design
ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: (01)18033509859908
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