medical Class II Updated 2023-07-05

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

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Affected States: 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
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
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