Exactech, Inc. recalls Exactech Ergo Impactor Handle, Catalog #321-09-05.

Recalled July 5, 2023 · FDA recall Z-2051-2023 · Exactech

Hazard

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

Units

784 devices

Sold at

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.

Description

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

Product

Exactech Ergo Impactor Handle, Catalog #321-09-05.

Manufacturer(s)

Exactech, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →