FDA Device recall Z-2396-2021
TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to…
- FDA Device
- Class II
- terminated
- Published 2021-09-08
On 2021-09-08 the FDA classified a Class II recall of TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to… by Depuy Orthopaedics, citing 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, cau….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2396-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-10 |
| Published | 2021-09-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Depuy Orthopaedics |
| Distribution | CA, CO, FL, IL, IN, MI, MN, NY, TX, WA |
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
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.
Identifiers
| code_info | Lot numbers: 28206, 27983 GTIN: 10603295430773 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Depuy Orthopaedics
- ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System
FDA Device · Class II · 2024-04-10 · Depuy Orthopaedics - Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
FDA Device · Class II · 2023-03-29 · Depuy Orthopaedics - Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
FDA Device · Class II · 2023-03-29 · Depuy Orthopaedics - Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
FDA Device · Class II · 2023-03-29 · Depuy Orthopaedics - Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
FDA Device · Class II · 2023-03-29 · Depuy Orthopaedics
All Depuy Orthopaedics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2396-2021%22
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