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Other Medical Devices

🏥 Medical Devices • 15,203 recalls

HENRY SCHEIN, ENT PACK, Item No.570-2718

Stradis Medical, LLC

Class I - Dangerous

Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

Nov 2, 2022 Other Medical Devices Nationwide View Details →

NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02

Zimmer

Class I - Dangerous

Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components as compared to other total knee arthroplasties in the United Kingdom National Joint Registry (UK NJR). Removing the NexGen Stemmed Option Tibial Component f rom inventory will prevent its future implantation with either the LPS Flex or LPS Flex GSF femoral components and mitigate the increased revision risk with these two specific combinations of tibial and femoral component.

Dec 6, 2022 Other Medical Devices Nationwide View Details →

STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS

Stradis Medical, LLC

Class I - Dangerous

Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

Nov 2, 2022 Other Medical Devices Nationwide View Details →
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