# FDA recall Z-0650-2021

> **ConMed Corporation** · Class II · device recall initiated 2020-11-12.

## Product

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

## Reason for recall

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

## Distribution

Nationwide  Foreign: Canada, Thailand, Taiwan, South Africa

## Key facts

- **Recall number:** Z-0650-2021
- **Recalling firm:** ConMed Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-12
- **Report date:** 2020-12-30
- **Termination date:** 2024-04-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Utica, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0650-2021

## Citation

> AI Analytics. FDA recall Z-0650-2021. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-0650-2021. Source: US FDA. Licensed CC0.

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