FDAJanuary 7, 2022device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

orthosoft inc dba zimmer casorthosoftorthosoft inc

UPCs

0088902430422220800000007

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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