ConMed Corporation recalls Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction.…
- Recall date
- November 12, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0650-2021
- FDA classification
- Class II
- Brand / firm
- ConMed Corporation
- Sold / distributed
- Nationwide Foreign: Canada, Thailand, Taiwan, South Africa
Why it was recalled
Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100
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