Skip to content
Recall Observatory FDA recall evidence

Derived label

Device software or design

PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981

reason.device_software_design

v1.0.0

Assignment summary

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

Field note

Send feedback

We'll only use this to respond to your feedback.