Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.

Class I - Dangerous

🏥 Medical Devices Recalled: December 5, 2014 Orthosensor Implants & Prosthetics

What Should You Do?

Check if you have this product:
Model SYK-TRCR 02, Lot # 091914V11770, Serial #s: 411654008, 411585023, 411654007, 411585032, 411585014, 411654016, 411585017, 411654015, 411585030, 411654020, 411654004, 411654010, 411585007, 411585005, 411654011, 411585036, 411585035, 411654018, 411654012, 411585011, 411654014, 411654005, 411654001, 411585003.
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:: Orthosensor, Inc.
Reason for Recall:: Presence of one inoperable (dead) sensor pad.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.

Product Codes/Lot Numbers:

Model SYK-TRCR 02, Lot # 091914V11770, Serial #s: 411654008, 411585023, 411654007, 411585032, 411585014, 411654016, 411585017, 411654015, 411585030, 411654020, 411654004, 411654010, 411585007, 411585005, 411654011, 411585036, 411585035, 411654018, 411654012, 411585011, 411654014, 411654005, 411654001, 411585003.