Agency classClass IIOur severity:High FDA (Devices)·Z-1499-2021·Announced 2021-05-05

ConMed Infinity ACL Tibial Guides Recalled for Potential Misalignment

ConMed Corporation is recalling three Infinity ACL Tibial Elbow and Tip Guides due to potential lateral misalignment that could affect surgical accuracy.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device defect that could affect surgical accuracy and require alternate methods, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.

Plain-English summary

ConMed Corporation is recalling three units of the KIT_INFINITY_BASE Custom Procedural Kit, which contains Infinity ACL Tibial Elbow and Tip Guides (models KTE100 and KTT100). These medical devices are used in open and arthroscopic procedures for knee ligament reconstruction. The specific units involved have serial numbers 1, 2, and 3.

The recall was initiated because the Tip Guides are potentially misaligned laterally. This defect could affect the accuracy of the guide system, potentially causing a delay in the procedure or requiring the use of another device or an alternate surgical method.

The affected products were distributed internationally in Canada and Italy. No specific illnesses or injuries have been reported in the source text. Healthcare providers and patients should contact ConMed Corporation for further instructions regarding the return or replacement of these devices.

The recalled product

Product: 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…
Manufacturer: ConMed Corporation
Category: Medical Device — Surgical Guides
Hazard: device-malfunction
surgical-error
Affected units: 3

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Serial Numbers: 1
2
3

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by ConMed Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · ConMed Corporation

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Same hazard · device malfunction