NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Check against the official notice below — it lists the full affected range.
Orthosoft, Inc. (operating as Zimmer CAS) is recalling the NavitrackER Kit A: Knee, Model Number 20-8000-000-07, due to a sterilization failure. The product was distributed without passing required sterilization results, which could mean the product is not sufficiently sterile. The most serious potential risk is surgical site infection that could require additional surgery. The affected lot is number 110221A1 with UDI Number (01)00889024304222 (17)231103(10)110221A1, and the product was distributed in the United States (in Arkansas, New York, Ohio, Tennessee, and Texas), Canada, and the Netherlands, totaling 14 units in the US and 132 units internationally.
The recall record does not specify what consumers or healthcare providers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide distribution in the states of AR, NY, OH, TN, TX and the countries of Canada and the Netherlands. Quantity: 14 units US; 132 units OUS Lot/code info: Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.