# FDA recall Z-2663-2017

> **Exactech, Inc.** · Class II · device recall initiated 2017-05-25.

## Product

EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01

## Reason for recall

Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.

## Distribution

AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, Hawaii  and Puerto Rico  Australia, Austria, Brazil, Canada, China, France, Germany, Greece, India, Italy, Korea, Luxembourg, Singapore, South Africa, Spain, Sweden, Switzerland, The Netherlands and United Kingdom

## Key facts

- **Recall number:** Z-2663-2017
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-25
- **Report date:** 2017-07-12
- **Termination date:** 2019-07-26

- **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-2663-2017

## Citation

> AI Analytics. FDA recall Z-2663-2017. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2663-2017. Source: US FDA. Licensed CC0.

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