INFINITY_TRAY Custom Procedural Kit — Class II medical device recall Z-1498-2021
Terminated recall by ConMed Corporation, reported 2021-05-05. Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could
| Recall number | Z-1498-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConMed Corporation, Utica, NY, United States |
| Recall initiated | 2021-03-26 |
| Classified | 2021-04-27 |
| Reported by FDA | 2021-05-05 |
| Terminated | 2024-04-05 |
| Countries outside the US | CA, IT |
| Quantity | 2 units |
| Serial numbers | 001, 005 |
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 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
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-1498-2021. 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.