# FDA recall Z-1499-2021

> **ConMed Corporation** · Class II · device recall initiated 2021-03-26.

## 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 product within the kits has its own product specific labeling.

## Reason for recall

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

## Distribution

International distribution in the countries of Canada, Italy.

## Key facts

- **Recall number:** Z-1499-2021
- **Recalling firm:** ConMed Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-26
- **Report date:** 2021-05-05
- **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-1499-2021

## Citation

> AI Analytics. FDA recall Z-1499-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1499-2021. Source: US FDA. Licensed CC0.

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