Exactech, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2051-2023)

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

Product Classification:

Class II

Date Initiated: June 5, 2023

Date Posted: July 5, 2023

Recall Number: Z-2051-2023

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: 784 devices

Code Information:

Catalog #321-09-05 - Lot numbers: 147544002, 275151004, 275151005, 275151006, 314934001, 400107002, and 400798002; UDI-DI 10885862557674. Updated data - 01/31/2025: Additional Lot Numbers 401819005 401819007 401819008 404552002 405492002 405253003 406041001

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