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Stradis Medical, LLC dba Stradis Healthcare Recall 89671

Description: Total Knee Pack - Surgical Kit

Stradis Medical, LLC dba Stradis Healthcare Recall 89671 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0864-2022
Event ID89671
Event DescriptionTotal Knee Pack - Surgical Kit
Product TypeDevices
DistributionUS Nationwide distribution in the states of IN, TX, and PA.
Quantity76 units
Recall ReasonThe outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Device Classification20220413
Device Code InfoSKU/Part Number 570-2676; UDI H65257026760 Lot Numbers: 20156461673, 20171461909, 20174462304, 20239463246, 20342468026, 21130473544, 21286478854, 21326479944, 22005482064
Center Classification Date20220404
Recall Initiation Date20220225
Recalling FirmStradis Medical, LLC dba Stradis Healthcare
Initial Notification Letter
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