Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments Recalled by DePuy Orthopaedics, Inc. Due to Software: A coding error associated with the Fast3D...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact DePuy Orthopaedics, Inc. directly.
Affected Products
TRUMATCH CT CUT GUIDE KIT 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: 420916
Quantity: 9 cases (1/cs)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 10 states: CA, CO, FL, IL, IN, MI, MN, NY, TX, WA
About DePuy Orthopaedics, Inc.
DePuy Orthopaedics, Inc. has 154 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report