Z-2989-2020 Class II Terminated
FDA device recall Z-2989-2020 was initiated by Wright Medical Technology Inc on August 26, 2020 and is designated Class II. Reason for recall: Lack of sterility assurance The recall status is terminated (terminated April 27, 2021). Affected quantity: 16 stems.
Recall Details
- Product Type
- Devices
- Report Date
- September 30, 2020
- Initiation Date
- August 26, 2020
- Termination Date
- April 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 stems
Product Description
EVOLVE STEM 8.5MM Model # 496S085
Reason for Recall
Lack of sterility assurance
Distribution Pattern
USA states: CA, CO, FL, GA, MA, MO, OH, PA, TX OUS: Australia, Canada, Chile, Israel, Spain
Code Information
Lot # 1668777