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Recall Observatory FDA recall evidence

Device product

TRUMATCH CT PIN GUIDE KIT L- 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: 420578

Z-2394-2021

August 10, 2021

Class II

Product summary

Firm
DePuy Orthopaedics, Inc.
Event
Event 88522
Status
Terminated
Classification
Class II
Quantity
4 cases (1/case)
Official record key
device-enforcement:Z-2394-2021

Official wording

Reason: Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.

Code information: Lot Numbers: 27932 , 27806, 27515, 27466, GTIN: 10603295430797

Distribution pattern: Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software: A coding error