KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100. For use in open and arthroscopic procedures for knee ligament reconstruction The procedural kits have no kit specific labeling. Each product within the kits has its own product specific labeling.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: 1, 2, 3
- 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:
- ConMed Corporation
- Reason for Recall:
- Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another device or alternate surgical method to be used
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100. For use in open and arthroscopic procedures for knee ligament reconstruction The procedural kits have no kit specific labeling. Each product within the kits has its own product specific labeling.
Product Codes/Lot Numbers:
Serial Numbers: 1, 2, 3
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1499-2021
Related Recalls
Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could require another device to be used.
Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another device or alternate surgical method to be used
Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system