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Recall Observatory FDA recall evidence

Derived label

Device software or design

VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H

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 Biomet, Inc.

Field note

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