# FDA recall Z-0872-2020

> **Exactech, Inc.** · Class II · device recall initiated 2019-12-03.

## Product

Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint work total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.

## Reason for recall

Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands.  The translations on the outer labels include the word " long"  in all languages other than the original English version.  The implants are standard length fracture stems.

## Distribution

International distribution in the countries of Australia; Austria; Brazil; Canada; China; Colombia: France; Germany; Guatemala, India; Italy; Japan; Luxembourg; Netherlands; Singapore; South Korea; Spain; Sweden: United Kingdom.

## Key facts

- **Recall number:** Z-0872-2020
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-03
- **Report date:** 2020-02-05
- **Termination date:** 2022-10-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gainesville, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0872-2020

## Citation

> AI Analytics. FDA recall Z-0872-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0872-2020. Source: US FDA. Licensed CC0.

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