ConMed recalls Infinity Tray Custom Procedural Kits (KTE100/KTT100) for possible lateral misalignment affecting surgical accuracy. Affected units sold in Canada with serial numbers 001, 005.
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
ConMed is recalling specific knee surgery kits that may be misaligned during use, which could delay procedures and require alternative surgical methods. This risk affects only certain kits sold in Canada with serial numbers 001 and 005.
The tip guides might not align properly laterally during surgery, which could lead to inaccurate guidance and require additional procedures or alternative surgical techniques.
Surgical teams using the Infinity ACL Tibial Elbow and Tip Guides kits in Canada. Those with serial numbers 001 or 005 are most at risk.
Check for the Infinity ACL Tibial Elbow and Tip Guides product line (KTE100/KTT100) in Canada. Affected kits have serial numbers 001 or 005.
Look for serial numbers 001 or 005 on the kit packaging.
The tip guides may be misaligned laterally, which could affect surgical accuracy and require alternative procedures.
Check if your kit has serial numbers 001 or 005; if so, stop using it and contact ConMed for instructions.
The risk is low as misalignment may delay procedures but does not cause serious injury in normal use.
We’ve drafted a message you can send ConMed to request your refund or repair — edit it as you like.
Subject: Recall Z-1498-2021 — ConMed ConMed Hello, I own a ConMed that is covered by recall Z-1498-2021 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.
