TruMatch CT Surgical Guidance Software Misalignment in Joint Replacement Instruments
DePuy Orthopaedics' TruMatch CT surgical instrument system has a software coding error that may prevent proper alignment of scanning images, potentially causing limb malalignment during joint replacement surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving surgical guidance software with potential for significant harm (limb malalignment). No injuries or illnesses reported, but the hazard represents a risk-of-harm product in a surgical context where misalignment could lead to patient injury.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling the TruMatch CT CUT GUIDE FEM L (Part Number 420917), a patient-specific surgical instrument system designed to assist in positioning joint replacement components and guiding bone-cutting during hip, knee, and ankle replacement surgeries.
A coding error in the Fast3D Segmentation software can cause the three required images (hip, knee, and ankle) to become misaligned during the scanning process. This misalignment may result in inaccurate anatomic landmark locations, potentially causing limb malalignment during the surgical procedure.
The affected instruments were distributed to medical facilities in California, Colorado, Florida, Illinois, Indiana, New York, Michigan, Minnesota, Texas, Washington, Poland, and the United Kingdom (Lot number/GTIN: 27958, 10603295384878).
The recalled product
- Product
- TRUMATCH CT CUT GUIDE FEM 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…
- Manufacturer
- DePuy Orthopaedics, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number/ GTIN: 27958 10603295384878
Distribution
Part of a larger recall action
This product is one of 7 recalled by DePuy Orthopaedics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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