TRUMATCH CT CUT 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: 420916
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics is recalling TRUMATCH CT CUT GUIDE KIT R, patient-specific surgical instruments used to assist in joint positioning during orthopedic procedures. A coding error in the Fast3D Segmentation software can cause misalignment of the three images (hip, knee, and ankle) taken during the scanning process, potentially resulting in incorrect anatomic landmark locations and limb malalignment during surgery.
The recall affects nine cases distributed to California, Colorado, Florida, Illinois, Indiana, New York, Michigan, Minnesota, Texas, Washington, Poland, and the United Kingdom. The affected lot numbers are 28226, 28135, 27612, 27544, 27431, 27407, 26970, 27476, and 27779. The source document does not specify what action 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: 9 cases (1/cs) Lot/code info: Lot number/ GTIN: 28226, 28135, 27612, 27544, 27431, 27407, 26970 OUS: 27476, 27779 GTIN: 10603295384861;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.