TRUMATCH CT FEM CUT TIB PIN 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: 420907
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics, Inc. recalled TruMatch CT FEM CUT TIB PIN R patient-specific surgical instruments due to a coding error in the Fast3D Segmentation software. The error can cause misalignment of three images (hip, knee, and ankle) taken during the scanning process, which may result in incorrect anatomic landmark locations and lead to limb malalignment during surgery.
The recalled products were distributed to California, Colorado, Florida, Illinois, Indiana, New York, Michigan, Minnesota, Texas, Washington, Poland, and the United Kingdom. Two cases were affected, with lot numbers 27975 and 27470. 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: 2 cases (1/cs) Lot/code info: Lot number/ GTIN: 27975, 27470 GTIN: 10603295384823
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.