FDA Device recall Z-1498-2021
INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100
- FDA Device
- Class II
- terminated
- Published 2021-05-05
On 2021-05-05 the FDA classified a Class II recall of INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100 by Conmed, citing 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 alternat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1498-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-26 |
| Published | 2021-05-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Conmed |
| Distribution | n/a |
Product
INFINITY_TRAY Custom Procedural Kit - Canada. 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
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
Identifiers
| code_info | Serial Numbers: 001, 005 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1498-2021%22
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