TRUMATCH CT CUT 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 Number: 420915
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics, Inc. is recalling TruMatch CT Cut Guide Kit L, which are patient-specific surgical instruments designed to help position joints during surgery. The recall affects 5 cases distributed to California, Colorado, Florida, Illinois, Indiana, New York, Michigan, Minnesota, Texas, Washington, Poland, and the United Kingdom. The affected lot numbers are 28289, 28247, 27876, 27432, and 27613.
A coding error in the Fast3D Segmentation software used during the scanning process may cause three required images of the hip, knee, and ankle to become misaligned. This misalignment could result in incorrect anatomic landmark locations, potentially leading to limb malalignment during surgery. The recall notice does not specify a remedy or recommended course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
Reason for recall: Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment. Distribution: Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK. Quantity: 5 cases ( 1/cs) Lot/code info: Lot number/ GTIN: 28289, 28247, 27876, 27432, 27613 (OUS) GTIN: 10603295384854
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.