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

Hazard

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

Details from the source

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. Quantity: 784 devices Lot/code info: 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

UPC codes

10885862557674

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.