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Orthosoft, Inc. dba Zimmer CAS Recall 89619

Description: NavitrackER Kit A: Knee, Model Number 20-8000-000-07,

Orthosoft, Inc. dba Zimmer CAS Recall 89619 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0721-2022
Event ID89619
Event DescriptionNavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of AR, NY, OH, TN, TX and the countries of Canada and the Netherlands.
Quantity14 units US; 132 units OUS
Recall ReasonThe product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention.
Device Classification20220309
Device Code InfoLot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1
Center Classification Date20220303
Recall Initiation Date20220107
Recalling FirmOrthosoft, Inc. dba Zimmer CAS
Initial Notification Letter
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