medical Class II Updated 2022-03-09

Orthosoft, Inc. dba Zimmer CAS recalls NavitrackER Kit A: Knee, Model Number 20-8000-000-07,

Recalled Product

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


Hazard / Issue

The 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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1
View official government recall

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