TRUMATCH CT CUT GUIDE FEM 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: 420917
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics, Inc. has recalled the TruMatch CT Cut Guide Fem L, a patient-specific surgical instrument used to assist in positioning joints during orthopedic procedures. The recall involves one case of devices with lot number 27958 that were distributed to California, Colorado, Florida, Illinois, Indiana, New York, Michigan, Minnesota, Texas, and Washington, as well as to Poland and the United Kingdom.
A coding error in the Fast3D Segmentation software used during the scanning process can cause misalignment of three required images of the hip, knee, and ankle. This misalignment may result in anatomic landmark locations being recorded incorrectly, potentially leading to limb malalignment in patients who receive surgery using the affected instruments. The source document does not specify a remedy or corrective 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: 1 cs (1/cs) Lot/code info: Lot number/ GTIN: 27958 10603295384878
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.