ConMed recalls Infinity ACL Tibial Elbow Guide for potential misalignment of tips, which could affect surgical accuracy during knee ligament reconstruction procedures.
Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system
ConMed is recalling its Infinity ACL Tibial Elbow Guide used in knee ligament surgery because the tips might be misaligned laterally. This could lead to inaccurate surgical guidance during procedures. Affected units have specific catalog numbers and lot codes listed in the recall notice.
The tips of the guide could be misaligned laterally during use, which might cause the guide to be less accurate. This could affect the precision of the surgical procedure, potentially leading to less effective ligament reconstruction.
Surgical teams using the Infinity ACL Tibial Elbow Guide for knee ligament reconstruction procedures are likely affected. Patients undergoing these surgeries may be at risk if the guide is misaligned.
Check for catalog number KTE100 and lot codes 201926AB, 201942AF, 201947AF, 202007AF, 202011AF, 202015AF, 202018AF, or 202024AF on the product packaging.
Look for catalog number KTE100 and lot codes listed in the recall notice to confirm if your device is affected.
The recall indicates a potential misalignment of tips that could affect accuracy, but the product is not unsafe for use unless the tips are misaligned. Affected units should be checked.
The recall does not specify a remedy, so check the product details against the listed catalog numbers and lot codes to determine if it is affected.
Check for catalog number KTE100 and lot codes 201926AB, 201942AF, 201947AF, 202007AF, 202011AF, 202015AF, 202018AF, or 202024AF on the product packaging.
We’ve drafted a message you can send ConMed to request your refund or repair — edit it as you like.
Subject: Recall Z-0650-2021 — ConMed ConMed Hello, I own a ConMed that is covered by recall Z-0650-2021 from ConMed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
