FDA recall Z-2050-2023

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

Status

Ongoing

Initiation date

2023-06-05

Report date

2023-07-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2050-2023