TruMatch Surgical Instruments Recalled for Software Alignment Error
DePuy Orthopaedics recalls TruMatch patient-specific surgical instruments due to a Fast3D software error that may misalign scanning images, potentially causing limb malalignment during surgery.
What this means for you
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 medical device recall involving a risk-of-harm product where the potential harm (surgical limb malalignment) is significant, but no injuries or illnesses have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
DePuy Orthopaedics is recalling TruMatch patient-specific surgical instruments due to a coding error in the Fast3D Segmentation software. These instruments are intended to assist in positioning joint replacement components during surgery and to guide bone marking before cutting.
A software coding error may prevent proper alignment of three images (hip, knee, and ankle) required during the scanning process. When these images are not properly aligned, the anatomic landmark locations may be incorrectly identified, potentially resulting in limb malalignment during joint replacement surgery.
The affected instruments bear Part Number 420907 and Lot numbers 27975 and 27470. They were distributed to healthcare facilities in California, Colorado, Florida, Illinois, Indiana, Michigan, Minnesota, New York, Texas, Washington, Poland, and the United Kingdom.
The recalled product
- Product
- TRUMATCH CT FEM CUT TIB PIN 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.
- Hazard
- surgical-misalignment
- software-error
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 (2)
- Lot number/ GTIN: 27975
- 27470 GTIN: 10603295384823
Distribution
Distributed in 10 states:
- CA
- CO
- FL
- IL
- IN
- MI
- MN
- NY
- TX
- WA
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