FDA Device recall Z-0650-2021
Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction
- FDA Device
- Class II
- terminated
- Published 2020-12-30
On 2020-12-30 the FDA classified a Class II recall of Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction by Conmed, citing tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0650-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-12 |
| Published | 2020-12-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Conmed |
| Distribution | US |
Product
Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100
Reason
Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system
Identifiers
| code_info | Lot Codes: 201926AB 201942AF 201947AF 202007AF 202011 AF 202015AF 202018AF 202024AF |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0650-2021%22
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