FDA recall Z-0603-2018
Exactech, Inc. · Class II · device
Product
Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
Reason for recall
Vix Bit may fracture during use.
Distribution
Worldwide Distribution: US states of Florida and California, Australia, France, Spain, and United Kingdom.
Key facts
- Status
- Terminated
- Initiation date
- 2017-07-11
- Report date
- 2018-02-21
- Termination date
- 2021-04-22
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Gainesville, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0603-2018