Surgical alignment software error recalled in patient-specific orthopedic instruments
DePuy Orthopaedics recalls TruMatch surgical instruments due to a software error in the scanning alignment tool that may cause incorrect limb positioning 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 recall involving a software error in surgical instrumentation that could cause limb malalignment. Although no injuries have been reported and the hazard is theoretical, the potential for surgical misalignment in orthopedic procedures warrants a High severity rating.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling TruMatch CT PIN GUIDE FEM R patient-specific surgical instruments (Part Number 420581) used during orthopedic joint replacement procedures. The devices are intended to assist in positioning joint replacement components and marking bone for cutting. The recall involves 2 cases distributed to U.S. states including California, Colorado, Florida, Illinois, Indiana, Michigan, Minnesota, New York, Texas, and Washington, as well as Poland and the United Kingdom.
A coding error in the Fast3D Segmentation software used during the scanning process prevents proper alignment of the three images required for hip, knee, and ankle scanning. This misalignment can result in inaccurate anatomic landmark locations, potentially causing incorrect limb positioning during surgery and bone preparation.
Affected orthopedic centers and surgical facilities should discontinue use of the recalled instruments and contact DePuy Orthopaedics for replacement guidance. No injuries or illnesses have been reported in connection with this issue to date. However, the potential for surgical misalignment in orthopedic procedures poses a risk to patient outcomes.
The recalled product
- Product
- TRUMATCH CT PIN GUIDE FEM 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 (2)
- Lot numbers: 28206
- 27983 GTIN: 10603295430773
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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