ConMed Recalls Infinity ACL Tibial Tip Guides Due to Misalignment
ConMed Corporation is recalling 95 Infinity ACL Tibial Tip Guides because the tips may be laterally misaligned, potentially affecting the accuracy of the guide system.
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 is classified as FDA Class II. The hazard involves a potential defect affecting the accuracy of a surgical guide, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
ConMed Corporation is recalling 95 units of the Infinity ACL Tibial Tip Guide (Catalog Number: KTT100). This medical device is indicated for use in open and arthroscopic procedures for knee ligament reconstruction. The recall covers 20 units distributed in the United States and 75 units distributed outside the United States, including Canada, Thailand, Taiwan, and South Africa.
The recall was initiated because 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. The affected lot codes are 201941AE, 201946AF, 202006AF, 202010AF, 202015AF, 202019AF, and 202023AF.
The U.S. Food and Drug Administration has classified this recall as Class II. Healthcare providers and patients should stop using the affected devices and contact ConMed Corporation for further instructions.
The recalled product
- Product
- Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTT100
- Manufacturer
- ConMed Corporation
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 (1)
- Lot Codes: 201941AE 201946AF 202006AF 202010AF 202015AF 202019AF 202023AF
Distribution
Distributed nationwide across the United States.
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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