The Recall Desk

FDA (Devices) recall action 86746

ConMed Corporation recalled 2 products on 2020-12-30

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-12-30
Critical
0
Units
—

Why these products were recalled

Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • HighFDA (Devices)··2020-12-30

    ConMed Recalls Infinity ACL Tibial Tip Guides Due to Misalignment

    ConMed Corporation is recalling 95 Infinity ACL Tibial Tip Guides because the tips may be laterally misaligned, potentially affecting the accuracy of the guide system.

    Product
    Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTT100
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-12-30

    ConMed Infinity ACL Tibial Elbow Guide Recalled for Misalignment

    ConMed Corporation is recalling 73 units of the Infinity ACL Tibial Elbow Guide because the tips may be misaligned, potentially affecting the accuracy of the guide system.

    Product
    Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100
    Category
    Distribution
    0 states