---
title: "Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Mo... — FDA record Z-0535-2026 | Is It on Recall"
description: "Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance cr"
url: https://isitonrecall.com/recall/fda-device-z-0535-2026-brand-name-equinoxe-ergo-product-name-adjustable-angle-rtsa-reamer-42mm-model-catalog-number-321-59/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software V... — FDA record Z-0535-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 5, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component
- **Reason**: Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
- **Classification**: Class II
- **Recalling firm**: Exactech, Inc.
- **Quantity**: 1
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0535-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0535-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot Code: Part Number: 321-59-42, UDI-DI: 10885862593009, Lot Number: 410398-013 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

U.S.: SC O.U.S.: N/A

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [South Carolina](https://isitonrecall.com/state/south-carolina/)

## Dates in the source

- **Report date**: Nov 26, 2025
- **Recall initiation date**: Sep 5, 2025
- **Center classification date**: Nov 17, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0535-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Exactech, Inc. records](https://isitonrecall.com/brand/exactech-inc/)