Surgical instrument software error may cause limb misalignment
DePuy Orthopaedics' TruMatch CT Pin Guide Kit has a software coding error that may misalign bone landmarks during joint replacement surgery, potentially causing limb malalignment. No injuries have been reported.
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: The software error could cause incorrect anatomic landmark positioning and result in limb malalignment during orthopedic surgery, a potentially serious complication. However, no injuries or illnesses have been reported, making this a theoretical hazard situation subject to the rubric's maximum score of 3.
Plain-English summary
The product being recalled is the TruMatch CT Pin Guide Kit R, manufactured by DePuy Orthopaedics, Inc. These patient-specific surgical instruments are designed to guide the positioning of joint replacement components during orthopedic surgery.
The FDA identified a coding error in the Fast3D Segmentation software associated with these kits. During the scanning process, the three images required to map the hip, knee, and ankle may not align properly. This misalignment could result in incorrect anatomic landmark locations, potentially causing limb malalignment during surgery.
Six cases of the affected kit have been distributed to surgical centers and hospitals in California, Colorado, Florida, Illinois, Indiana, Michigan, Minnesota, New York, Texas, Washington, Poland, and the United Kingdom. The affected lot numbers are 27929, 27855, 27667, 27591, 27521, and 27332 (GTIN 10603295430803).
No injuries or illnesses have been reported at this time. Healthcare facilities using this equipment should contact DePuy Orthopaedics, Inc. immediately to address the software issue and determine appropriate corrective actions.
The recalled product
- Product
- TRUMATCH CT PIN 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 (6)
- Lot number/ GTIN: 27929
- 27855
- 27667
- 27591
- 27521
- 27332 GTIN 10603295430803
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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