Z-2051-2023 Class II Ongoing
FDA device recall Z-2051-2023 was initiated by Exactech, Inc. on June 5, 2023 and is designated Class II. Reason for recall: The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction. The recall status is ongoing. Affected quantity: 784 devices.
Recall Details
- Product Type
- Devices
- Report Date
- July 5, 2023
- Initiation Date
- June 5, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 784 devices
Product Description
Exactech Ergo Impactor Handle, Catalog #321-09-05.
Reason for Recall
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
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.
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