Lower riskMedical device recall · FDA · Published November 12, 2020
ConMed Infinity ACL Tibial Tip Guide Recall: Potential Misalignment Risk
ConMed recalls Infinity ACL Tibial Tip Guides for possible lateral misalignment during knee ligament surgery. Affected units have specific catalog numbers and lot codes. Contact ConMed for details.
“ConMed Infinity ACL Tibial Tip Guide Recall: Potential Misalignment Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63924-conmed-infinity-acl-tibial-tip-guide-recall-potential-misalignment-risk. Based on FDA recall #Z-0651-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0651-2021%22&limit=1).
The FDA announced on November 12, 2020, that ConMed Corporation is recalling Infinity ACL Tibial Tip Guides due to potentially misaligned tips that could affect accuracy. The agency issued recall number Z-0651-2021 for the Class II device.
How to tell if you have it
Brand: ConMed
Product: Infinity ACL Tibial Tip Guide
Catalog Number: KTT100
Lot Codes: 201941AE, 201946AF, 202006AF, 202010AF, 202015AF, 202019AF, 202023AF
The hazard
According to the FDA, the tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally. This defect could affect the accuracy of the guide system during use.
Context
GovInfoNow's records show ConMed Corporation has 7 other recalls on record since June 19, 2017. Recent ConMed recalls include a July 14, 2026 suture anchor recall for incorrect implant card risk and a May 14, 2026 AirSeal 5mm Access Port recall for overpressure alerts. Other recent recalls of similar products include the U2 Total Knee System Femoral Offset Bushing Recall (March 19, 2026), Think Surgical TMINI Tracking Arrays recall (May 8, 2026), and Encore Medical EMPOWR 3D Knee Tibial Insert 5R 14MM Recall (January 5, 2026).
How to tell if you have this one
Check for catalog number KTT100 and lot codes 201941AE, 201946AF, 202006AF, 202010AF, 202015AF, 202019AF, or 202023AF on the product packaging.
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
Nationwide Foreign: Canada, Thailand, Taiwan, South Africa
Recall number
Product, codes & lots
Quantity
Z-0650-2021
Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100; Lot Codes: 201926AB 201942AF 201947AF 202007AF 202011 AF 202015AF 202018AF 202024AF
73 total: 23 units US;50 units OUS
Z-0651-2021
Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTT100; Lot Codes: 201941AE 201946AF 202006AF 202010AF 202015AF 202019AF 202023AF
95 total: 20 units US and 75 units OUS
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the catalog number and lot codes on the product packaging to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Nationwide Foreign: Canada, Thailand, Taiwan, South Africa” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.4 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-0651-2021 (November 12, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0651-2021 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.