Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: 1) 15090103 & 15150005, 15150006, 15150007, 15150008, 15150009, 15150010, 15150011, 15150012, 15130004, 15250013, 15250014, 15250015, 15250016, 15250017, 15300018 & 15300020, 2) 15050001, 15300005 & 15300006
- 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:
- Miscalibration of the Energy Source monitoring function, which may incorrectly sense the handpiece temperature as higher than the actual handpiece's temperature. This causes some devices to generate a "Check Seal" message with an audible alarm and to stop the heating cycle.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source.
Product Codes/Lot Numbers:
Serial Numbers: 1) 15090103 & 15150005, 15150006, 15150007, 15150008, 15150009, 15150010, 15150011, 15150012, 15130004, 15250013, 15250014, 15250015, 15250016, 15250017, 15300018 & 15300020, 2) 15050001, 15300005 & 15300006
Distribution:
Distributed in: CA, TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0359-2016
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
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