2 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;
FDA Enforcement
Class II
·Terminated·Deroyal Industries, Inc. Lafollette·March 11, 2020
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021