Exactech, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2050-2023)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2023.
Data Source: FDA.
Product Description:
Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.
Product Classification:
Class II
Date Initiated: June 5, 2023
Date Posted: July 5, 2023
Recall Number: Z-2050-2023
Event ID: 92414
Reason for Recall:
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
Status: Ongoing
Product Quantity: 250 devices
Code Information:
Catalog #531-07-05 - Lot numbers: 154287001, 295878002, and 302331004; UDI-DI 10885862542038.
Distribution Pattern:
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.
Voluntary or Mandated:
Voluntary: Firm initiated