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Recall

Class II — ConMed Corporation

Recalling firmCONMED CORPORATION
Registered facilityView this company's 6 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonTip 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
ProductKIT_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.
Quantity3 units
DistributionInternational distribution in the countries of Canada, Italy.
Initiated2021-03-26
Classified2021-04-27
Terminated2024-04-05
Recall numberZ-1499-2021
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — ConMed Corporation (Z-1499-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87578/

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