Infinity ACL Tibial Elbow Guide-indicated for use in open and… — Class II medical device recall Z-0650-2021
Terminated recall by ConMed Corporation, reported 2020-12-30, distributed nationwide. Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect t
| Recall number | Z-0650-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConMed Corporation, Utica, NY, United States |
| Recall initiated | 2020-11-12 |
| Classified | 2020-12-21 |
| Reported by FDA | 2020-12-30 |
| Terminated | 2024-04-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, TH, TW, ZA |
| Lot numbers | 201926AB, 201942AF, 201947AF, 202007AF, 202011AF, 202015AF, 202018AF, 202024AF |
| Model numbers | KTE100 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0650-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.