FDAClass IIDecember 30, 2020

Infinity ACL Tibial Elbow Guide-indicated for use in recall

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

Why was Infinity ACL Tibial Elbow Guide-indicated for use in recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Codes: 201926AB 201942AF 201947AF 202007AF 202011 AF 202015AF 202018AF 202024AF

Product
Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100
Recalling firm
ConMed Corporation
Quantity
73 total: 23 units US;50 units OUS
Distribution
Nationwide Foreign: Canada, Thailand, Taiwan, South Africa
Recall date
December 30, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls