Recall Z-0651-2021 ยท LXH Orthopedic Manual Surgical Instrument
ConMed Corporation
Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTT100
| Date | Nov 12, 2020 |
| Status | Terminated |
| Reason | Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system |
| Root cause | Process control |
| Action | Conmed issued Urgent Medical Device Recall lettersvia USPS First Class November 12, 2020 stating reason for recall, health risk and action to take: 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. It is imperative that all end users of these devices receive this notice and respond immediately. If you HAVE inventory of any of unused devices from the affected lot codes still in their original intact |
| Quantity | 95 total: 20 units US and 75 units OUS |
| Distribution | Nationwide Foreign: Canada, Thailand, Taiwan, South Africa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.