FDA-Device2020-12-30Class II
Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100
Hazard
Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system
Sold states
Nationwide Foreign: Canada, Thailand, Taiwan, South Africa
Affected count
73 total: 23 units US;50 units OUS
Manufactured in
525 French Rd, N/A, Utica, NY, United States
Products
Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0650-2021More ConMed Corporation recalls
- FDA-Device2026-06-24ConMed AirSeal 5mm Access Port recalled for potential overpressure alerts during laparoscopy
- FDA-Device2026-06-24ConMed AirSeal 12mm Access Port recalled for overpressure alert malfunction
- FDA-Device2026-06-24ConMed AirSeal 12mm Access Port recalled for overpressure alert risk
- FDA-Device2026-06-24ConMed AirSeal 5mm Access Port recalled for potential overpressure alerts
- FDA-Device2026-06-24ConMed AirSeal 8mm Access Port recalled for potential overpressure alerts
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