Evolve Stem 8.5mm recall: Sterility Concern
EVOLVE STEM 8.5MM Model # 496S085
Why was Evolve Stem 8.5mm recalled?
Lack of sterility assurance
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 1668777
- Product
- EVOLVE STEM 8.5MM Model # 496S085
- Recalling firm
- Wright Medical Technology Inc
- Quantity
- 16 stems
- Distribution
- USA states: CA, CO, FL, GA, MA, MO, OH, PA, TX OUS: Australia, Canada, Chile, Israel, Spain
- Recall date
- September 30, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)