Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN 10885862001924, Serial Numbers: A649282, A649289
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Exactech, Inc.
- Reason for Recall:
- Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
Product Codes/Lot Numbers:
GTIN 10885862001924, Serial Numbers: A649282, A649289
Distribution:
Distributed in: US, NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR, UK
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0584-2024
Related Recalls
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.