FDA-Device2021-05-05Class II
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.
ConMed Corporation
Hazard
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
Sold states
International distribution in the countries of Canada, Italy.
Affected count
3 units
Manufactured in
525 French Rd, N/A, Utica, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1499-2021Don't want to check this manually?
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