ConMed Corporation Recall 87578
Description: KIT_INFINITY_BASE Custom Procedural Kit - Italy, 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.
ConMed Corporation Recall 87578 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1499-2021 |
| Event ID | 87578 |
| Event Description | KIT_INFINITY_BASE Custom Procedural Kit - Italy, 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. |
| Product Type | Devices |
| Distribution | International distribution in the countries of Canada, Italy. |
| Quantity | 3 units |
| Recall 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 |
| Device Classification | 20210505 |
| Device Code Info | Serial Numbers: 1, 2, 3 |
| Center Classification Date | 20210427 |
| Recall Initiation Date | 20210326 |
| Recalling Firm | ConMed Corporation |
| Initial Notification | Letter |
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