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: 420579
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics has recalled the TruMatch CT PIN Guide Kit R, which consists of patient-specific surgical instruments designed to assist in positioning joints during surgery. The recall affects six cases distributed to California, Colorado, Florida, Illinois, Indiana, New York, Michigan, Minnesota, Texas, Washington, Poland, and the United Kingdom. The affected lot numbers are 27929, 27855, 27667, 27591, 27521, and 27332.
The recall was issued due to a coding error in the Fast3D Segmentation software used during the scanning process. This error can prevent proper alignment of the three images required for hip, knee, and ankle scanning, which may cause anatomic landmark locations to be inaccurate and potentially result in limb malalignment. The source document does not specify what actions affected consumers should take.
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: 6 cases (1/Cs) Lot/code info: Lot number/ GTIN: 27929, 27855, 27667, 27591, 27521, 27332 GTIN 10603295430803
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.