Surgical alignment software error recalled in patient-specific orthopedic instruments

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.

Category

Medical Device — Orthopedic Surgical Instruments

Hazard

• software-error
• surgical-misalignment
• limb-alignment-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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