Derived label

Device software or design

Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 54MM DIA, ENDO FEMORAL HEAD 48MM DIA, ENDO FEMORAL HEAD 41MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 44MM DIA, ENDO FEMORAL HEAD 45MM DIA, ENDO FEMORAL HEAD 46MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 48MM DIA, ENDO FEMORAL HEAD 49MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 51MM DIA, ENDO FEMORAL HEAD 52MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 54MM DIA, ENDO FEMORAL HEAD 55MM DIA

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: design verification test failures
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Zimmer, Inc.