CT Pin Guide Instruments Recalled for Software Imaging Alignment Error
The TruMatch CT Pin Guide Kit is being recalled due to a software error that may misalign surgical guidance images, potentially affecting limb positioning during hip, knee, and ankle surgery. 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: FDA Class II recall. While the software error creates a risk of improper limb alignment during surgery, no injuries or adverse events have been reported. This qualifies as a high-severity risk-of-harm situation where potential for injury exists but no harm has yet occurred.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling the TruMatch CT Pin Guide Kit, a set of patient-specific surgical instruments used to assist in positioning joint replacement components during orthopedic surgery. The recalled lot numbers are 27932, 27806, 27515, and 27466.
The recall was issued due to a software error in the Fast3D Segmentation software associated with these instruments. During the scanning process, the three required images of the hip, knee, and ankle may not be properly aligned. This alignment failure can cause the anatomic landmark locations to be positioned incorrectly, potentially resulting in improper limb alignment after surgery.
The affected devices were distributed to the following U.S. states: California, Colorado, Florida, Illinois, Indiana, New York, Michigan, Minnesota, Texas, and Washington, as well as to Poland and the United Kingdom. If you have received these instruments, contact DePuy Orthopaedics, Inc. for instructions regarding product return or replacement. No injuries or adverse events related to this issue have been reported to the FDA at this time.
The recalled product
- Product
- TRUMATCH CT PIN 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…
- 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 Numbers: 27932
- 27806
- 27515
- 27466
- GTIN: 10603295430797
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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