Derived label

Device software or design

RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment (CORE TM) System. When used with a variety of accessories, the RemB Electric Universal Driver is intended for surgical procedures involving driving wire or pins into bone and hard tissue. This includes but is not limited to Dental, ENT (Ear, Nose, Throat), Neuro, and Endoscopic applications. This device can also be used with the Total Performance System (TPSTM).

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: software. Handpieces that have been programmed with the incorrect
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Stryker Instruments Div. of Stryker Corporation