medical Class II Updated 2021-05-05

ConMed Corporation recalls INFINITY_TRAY Custom Procedural Kit - Canada. containing I

Recalled Product

INFINITY_TRAY Custom Procedural Kit - Canada. 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.


Hazard / Issue

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

Issued by

FDA

Distribution: International distribution in the countries of Canada, Italy.
Lot/Code Info: Serial Numbers: 001, 005
View official government recall

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