DePuy TruMatch CT Cut Guide Kit Recalled for Software Alignment Error
DePuy's TruMatch CT Cut Guide Kit is being recalled due to a software coding error that may cause misalignment of preoperative surgical positioning scans, potentially resulting in improper limb alignment 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: This is an FDA Class II recall of a surgical guidance device with a software error capable of causing surgical misalignment and limb malalignment. No injuries or hospitalizations are reported in the source, making this a theoretical risk-of-harm situation rather than a confirmed harm event.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling the TRUMATCH CT CUT GUIDE KIT R, patient-specific surgical instruments designed to assist in positioning joint replacement components during surgery and guiding bone marking. The recalled kits include 9 cases identified by lot numbers 28226, 28135, 27612, 27544, 27431, 27407, 26970 (US distribution) and 27476, 27779 (international distribution).
The recall was triggered by a coding error in the Fast3D Segmentation software used to process preoperative CT scans. During the scanning process, the three images required for hip, knee, and ankle positioning may not align properly with each other. This misalignment could cause anatomic landmark locations to be identified incorrectly, potentially resulting in improper limb alignment during the joint replacement surgical procedure.
The affected kits were distributed to surgical facilities in California, Colorado, Florida, Illinois, Indiana, Michigan, Minnesota, New York, Texas, and Washington, as well as to facilities in Poland and the United Kingdom.
The recalled product
- Product
- 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…
- 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 (8)
- Lot number/ GTIN: 28226
- 28135
- 27612
- 27544
- 27431
- 27407
- 26970 OUS: 27476
- 27779 GTIN: 10603295384861
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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