ConMed Corporation recalls KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE1…

Recall date

March 26, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1499-2021

FDA classification

Class II

Brand / firm

ConMed Corporation

Sold / distributed

International distribution in the countries of Canada, Italy.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.