Medical Device Recall: TruMatch CT Cut Guide Kit Software Misalignment Error
DePuy Orthopaedics is recalling TruMatch CT Cut Guide Kits due to a software coding error in the Fast3D Segmentation software that may cause improper alignment of anatomic images, potentially resulting in limb malalignment during 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 device recall involving a software error that could cause surgical misalignment. No illnesses or injuries are reported in the source text; the hazard is potential rather than confirmed. However, the risk of improper limb alignment during joint replacement surgery is significant, warranting a High severity classification.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling TruMatch CT Cut Guide Kit L (Part Number 420915) patient-specific surgical instruments. These instruments are intended to assist in positioning joint replacement components and guiding bone marking during orthopedic surgery.
A coding error in the Fast3D Segmentation software used during surgical planning can cause improper alignment of the three required anatomic images (hip, knee, and ankle). This misalignment may cause anatomic landmark locations to be incorrectly identified, potentially resulting in limb malalignment during the surgical procedure.
The affected product was distributed to surgical centers in California, Colorado, Florida, Illinois, Indiana, New York, Michigan, Minnesota, Texas, Washington, Poland, and the United Kingdom. Affected lot numbers include 28289, 28247, 27876, 27432, and 27613. Healthcare facilities and surgeons using these instruments with the affected lot numbers should stop using them immediately and contact DePuy Orthopaedics for replacement options and corrected software.
The recalled product
- Product
- TRUMATCH CT CUT 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…
- 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 (5)
- Lot number/ GTIN: 28289
- 28247
- 27876
- 27432
- 27613 (OUS) GTIN: 10603295384854
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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