TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments… — Class II medical device recall Z-2395-2021
Terminated recall by DePuy Orthopaedics, Inc., reported 2021-09-08, distributed in CA, CO, FL, IL, IN, MI, MN, NY…. Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the thr
| Recall number | Z-2395-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2021-08-10 |
| Classified | 2021-09-01 |
| Reported by FDA | 2021-09-08 |
| Terminated | 2023-05-17 |
| Distributed | CA, CO, FL, IL, IN, MI, MN, NY, TX, WA |
| Countries outside the US | GB, PL |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 10603295430803 |
| Model numbers | 420579 |
Product
TRUMATCH CT PIN 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: 420579
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2395-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.