INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guid...
FDA Device Recall #Z-1498-2021 — Class II — March 26, 2021
Recall Summary
| Recall Number | Z-1498-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 26, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ConMed Corporation |
| Location | Utica, NY |
| Product Type | Devices |
| Quantity | 2 units |
Product Description
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
Distribution Pattern
International distribution in the countries of Canada, Italy.
Lot / Code Information
Serial Numbers: 001, 005
Other Recalls from ConMed Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0474-2023 | Class II | Foot Controlled Electrosurgical Suction Coagula... | Nov 18, 2022 |
| Z-1499-2021 | Class II | KIT_INFINITY_BASE Custom Procedural Kit - Italy... | Mar 26, 2021 |
| Z-0650-2021 | Class II | Infinity ACL Tibial Elbow Guide-indicated for u... | Nov 12, 2020 |
| Z-0651-2021 | Class II | Infinity ACL Tibial Tip Guide- indicated for u... | Nov 12, 2020 |
| Z-1304-2019 | Class II | ConMed Anchor Tissue Retrieval System 10 MM, 23... | Mar 21, 2019 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.