Derived label
Device software or design
Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Sterile, RX.
Assignment summary
- Mode key
- device_software_design
- Evidence excerpt
- design incompatibility
- Rule explanation
- Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
- Firm
- Exactech, Inc.