Z-2050-2023 Class II Ongoing
FDA device recall Z-2050-2023 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: 250 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
- 250 devices
Product Description
Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.
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 #531-07-05 - Lot numbers: 154287001, 295878002, and 302331004; UDI-DI 10885862542038.