Device product
Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.
Z-2050-2023
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 92414
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 250 devices
- Official record key
device-enforcement:Z-2050-2023
Official wording
Reason: The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
Code information: Catalog #531-07-05 - Lot numbers: 154287001, 295878002, and 302331004; UDI-DI 10885862542038.
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.
Derived failure modes
-
Unknown
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.