FDA recall Z-2989-2020
Wright Medical Technology Inc · Class II · device
Product
EVOLVE STEM 8.5MM Model # 496S085
Reason for recall
Lack of sterility assurance
Distribution
USA states: CA, CO, FL, GA, MA, MO, OH, PA, TX OUS: Australia, Canada, Chile, Israel, Spain
Key facts
- Status
- Terminated
- Initiation date
- 2020-08-26
- Report date
- 2020-09-30
- Termination date
- 2021-04-27
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Arlington, TN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2989-2020