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: 420581
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics is recalling TruMatch CT Pin Guide Fem R patient-specific surgical instruments due to a software coding error in the Fast3D Segmentation software. During the scanning process, the three images required of the hip, knee, and ankle may not align properly, which could cause anatomic landmark locations to be inaccurate and potentially result in limb malalignment. The affected instruments were distributed to California, Colorado, Florida, Illinois, Indiana, New York, Michigan, Minnesota, Texas, and Washington, as well as to Poland and the United Kingdom. The recall involves 2 cases with lot numbers 28206 and 27983.
The recall notice does not specify a remedy or what affected consumers should do.
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: 2 cases (1 case) Lot/code info: Lot numbers: 28206, 27983 GTIN: 10603295430773
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.