Recall Z-1499-2021 ยท LXH Orthopedic Manual Surgical Instrument
ConMed Corporation
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.
| Date | Mar 26, 2021 |
| Status | Terminated |
| 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 |
| Root cause | Process control |
| Action | Conmed issued international notices Urgent Field Notice via UPS Priority on March 26, 202. Letter states reason for recall, health risk and action to take: Step 1: Please review your inventory for any of the devices with the affected lot codes listed on Attachment I. We ask that you contact all those departments within your facility and all other facilities that may have received affected products from you. Please forward a copy of this notice to all facilities which may have affected products in their inventory. It is imperative that all end users of these devices receive this notice and res |
| Quantity | 3 units |
| Distribution | International distribution in the countries of Canada, Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.