# FDA recall Z-2050-2023

> **Exactech, Inc.** · Class II · device recall initiated 2023-06-05.

## Product

Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.

## Reason for recall

The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.

## Distribution

Distribution was made to AR, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY,  LA, MD, ME, MN, NH, NV, NY, OH, OK, PA, SC, TN, TX,  WI, as well as PR.   There was no government/military distribution.    Foreign distribution was made to Australia, France, and Japan.

## Key facts

- **Recall number:** Z-2050-2023
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-05
- **Report date:** 2023-07-05

- **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-2050-2023

## Citation

> AI Analytics. FDA recall Z-2050-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-2050-2023. Source: US FDA. Licensed CC0.

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