DePuy Orthopaedics, Inc. Recall 88522
Description: TRUMATCH CT CUT 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: 420915
DePuy Orthopaedics, Inc. Recall 88522 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2398-2021 |
| Event ID | 88522 |
| Event Description | TRUMATCH CT CUT 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: 420915 |
| Product Type | Devices |
| Distribution | Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK. |
| Quantity | 5 cases ( 1/cs) |
| Recall 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. |
| Device Classification | 20210908 |
| Device Code Info | Lot number/ GTIN: 28289, 28247, 27876, 27432, 27613 (OUS) GTIN: 10603295384854 |
| Center Classification Date | 20210901 |
| Recall Initiation Date | 20210810 |
| Recalling Firm | DePuy Orthopaedics, Inc. |
| Initial Notification | Letter |
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