Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
Class I - DangerousWhat Should You Do?
- Check if you have this product: a) 02-012-47-3011, GTIN 10885862174352, Serial Numbers: A676497; b) 02-012-47-5009, GTIN 10885862174543, Serial Numbers: A641353; c) 02-012-47-5011, GTIN 10885862174550, Serial Numbers: A641341; d) 02-012-65-3013, GTIN 10885862613400, Serial Numbers: A655561
- 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 Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
Product Codes/Lot Numbers:
a) 02-012-47-3011, GTIN 10885862174352, Serial Numbers: A676497; b) 02-012-47-5009, GTIN 10885862174543, Serial Numbers: A641353; c) 02-012-47-5011, GTIN 10885862174550, Serial Numbers: A641341; d) 02-012-65-3013, GTIN 10885862613400, Serial Numbers: A655561
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-0583-2024
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.