ConMed Infinity Tray Custom Procedural Kit Recalled for Misaligned Guides
ConMed Corporation is recalling two Infinity Tray Custom Procedural Kits in Canada and Italy because the tip guides may be misaligned, potentially affecting surgical accuracy.
What this means for you
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 where a defect could affect surgical accuracy and require alternate methods, representing a risk of harm where injury has not yet been reported.
Plain-English summary
ConMed Corporation is recalling two units of the Infinity Tray Custom Procedural Kit, which contains Infinity ACL Tibial Elbow and Tip Guides (product codes KTE100 and KTT100). These kits are used in open and arthroscopic procedures for knee ligament reconstruction. The affected units have serial numbers 001 and 005 and were distributed internationally in Canada and Italy.
The recall was initiated because the tip guides are potentially misaligned laterally. This misalignment 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.
Healthcare providers and facilities that have received these specific kits should stop using them and contact ConMed Corporation for instructions on how to proceed.
The recalled product
- Product
- 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 w
- Manufacturer
- ConMed Corporation
- Affected units
- 2
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 (2)
- Serial Numbers: 001
- 005
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.
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