PlainRecalls
FDA Devices Moderate Class II Terminated

EVOLVE STEM 8.5MM Model # 496S085

Reported: September 30, 2020 Initiated: August 26, 2020 #Z-2989-2020

Product Description

EVOLVE STEM 8.5MM Model # 496S085

Reason for Recall

Lack of sterility assurance

Details

Units Affected
16 stems
Distribution
USA states: CA, CO, FL, GA, MA, MO, OH, PA, TX OUS: Australia, Canada, Chile, Israel, Spain
Location
Arlington, TN

Frequently Asked Questions

What product was recalled?
EVOLVE STEM 8.5MM Model # 496S085. Recalled by Wright Medical Technology Inc. Units affected: 16 stems.
Why was this product recalled?
Lack of sterility assurance
Which agency issued this recall?
This recall was issued by the FDA Devices on September 30, 2020. Severity: Moderate. Recall number: Z-2989-2020.