Device product
TRUMATCH CT PIN GUIDE FEM 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: 420581
Z-2396-2021
Product summary
- Event
- Event 88522
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 cases (1 case)
- Official record key
device-enforcement:Z-2396-2021
Official wording
Reason: 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.
Code information: Lot numbers: 28206, 27983 GTIN: 10603295430773
Distribution pattern: Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.
Derived failure modes
-
Device software or design
Software: A coding error