Surgical instrument software error may cause limb misalignment

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.

Category

Medical Device — Surgical Instruments / Orthopedic

Hazard

• software-error
• patient-positioning-error
• surgical-misalignment

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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