TRUMATCH CT PIN 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: 420578
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics, Inc. is recalling TruMatch CT PIN Guide Kit L devices due to a software error in the Fast3D Segmentation software used during the scanning process. The error can cause the three images taken of the hip, knee, and ankle to become misaligned, which may result in incorrect identification of anatomic landmarks and potentially cause limb misalignment during surgery. The affected devices were distributed to California, Colorado, Florida, Illinois, Indiana, New York, Michigan, Minnesota, Texas, Washington, Poland, and the United Kingdom.
The recall involves four cases (one device per case) with lot numbers 27932, 27806, 27515, and 27466. The source document does not specify what actions affected consumers should take regarding this recall.
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: 4 cases (1/case) Lot/code info: Lot Numbers: 27932 , 27806, 27515, 27466, GTIN: 10603295430797
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.