# FDA recall Z-0168-2020

> **Exactech, Inc.** · Class II · device recall initiated 2019-09-10.

## Product

Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacement. The wire is single-use, provided sterile, and intended for transient use.

## Reason for recall

Potential for the wire to fracture at the threads and remain in the glenoid.

## Distribution

US Nationwide including the states of AR, AZ, CA, CO, FL, IL, IN, KS, LA, MN, NY, NY, OH, SC, TN, TX, VA, WA.

## Key facts

- **Recall number:** Z-0168-2020
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-10
- **Report date:** 2019-10-30
- **Termination date:** 2023-05-01

- **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-0168-2020

## Citation

> AI Analytics. FDA recall Z-0168-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0168-2020. Source: US FDA. Licensed CC0.

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