The Recall Desk

FDA (Devices) recall action 87578

ConMed Corporation recalled 2 products on 2021-05-05

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
2021-05-05
Critical
0
Units
5

Why these products were 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

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2021-05-05

    ConMed Infinity ACL Tibial Guides Recalled for Potential Misalignment

    ConMed Corporation is recalling three Infinity ACL Tibial Elbow and Tip Guides due to potential lateral misalignment that could affect surgical accuracy.

    Product
    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 produc
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-05-05

    ConMed Infinity Tray Custom Procedural Kit Recalled for Misaligned Guides

    ConMed Corporation is recalling two Infinity Tray Custom Procedural Kits in Canada and Italy because the tip guides may be misaligned, potentially affecting surgical accuracy.

    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 w
    Category
    Distribution
    0 states