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Recall Observatory FDA recall evidence

Derived label

Device software or design

TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420581

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
Software: A coding error
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
DePuy Orthopaedics, Inc.

Field note

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