ConMed recalls certain KIT_INFINITY_BASE Custom Procedural Kits for possible lateral misalignment of tip guides, which may delay surgery or require alternative procedures.
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
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Contact the company
📍Recalling firmConMed Corporation525 French Rd · Utica, NY 13502-5945
“ConMed KIT_INFINITY_BASE Procedural Kit Recall: Potential Misalignment Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62898-conmed-kit-infinity-base-procedural-kit-recall-potential-misalignment-risk. Based on FDA recall #Z-1499-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1499-2021%22&limit=1).
The FDA announced on March 26, 2021, that ConMed Corporation voluntarily recalled the KIT_INFINITY_BASE Custom Procedural Kit - Italy containing Infinity ACL Tibial Elbow and Tip Guides. The hazard is that tip guides may be laterally misaligned, potentially affecting accuracy and causing procedural delays.
Product line: Infinity ACL Tibial Elbow and Tip Guides
Model numbers: KTE100, KTT100
Serial Numbers: 1, 2, 3
Distribution: Canada, Italy
The hazard
According to the FDA, the Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system. This misalignment could cause a delay in procedure and may require another device or alternate surgical method to be used.
Context
GovInfoNow's records show ConMed Corporation has had 7 other recalls since June 19, 2017. Recent ConMed recalls include the July 14, 2026 Suture Anchor Recall for incorrect implant cards and the May 14, 2026 AirSeal 5mm Access Port Recall for overpressure alerts. Other recent recalls of similar products include the June 10, 2026 Medline Knee Surgery Kits recall due to sterility risk and the March 19, 2026 U2 Total Knee System Femoral Offset Bushing recall for incorrect implant orientation.
How to tell if you have this one
Check for kits labeled KIT_INFINITY_BASE Custom Procedural Kit with serial numbers 1, 2, or 3. These kits were sold in Italy for knee ligament reconstruction procedures.
Brand
ConMed
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
International distribution in the countries of Canada, Italy.
Recall number
Product, codes & lots
Quantity
Z-1498-2021
INFINITY_TRAY Custom Procedural Kit - Canada. 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.; Serial Numbers: 001, 005
2 units
Z-1499-2021
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.; Serial Numbers: 1, 2, 3
3 units
Based on the official FDA remedy
What to do — step by step
Check Kit Serial Numbers
Look for serial numbers 1, 2, or 3 on the kit packaging or labels.
How this recall unfolded
Recall timeline
FDA terminated this recall 3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1499-2021 (March 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1499-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.