3 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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VITEK¿ 2 Gram Positive Susceptibility card (AST-P608), REF 22336, 20 cards per carton.
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·June 21, 2017
VITEK 2 Gram Positive Susceptibility card (AST-P608), REF 22336, 20 cards per carton.
FDA Recall
Terminated
·Biomerieux Inc·Product code N/A·April 20, 2017
Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for implantation with bone cement, with the exception of the porous coated femoral components which can be used cemented or uncemented (biological fixation).
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·March 30, 2016