Summary
The FDA issued a Class II for NavitrackER Kit A: Knee, Model Number 20-8000-000-07, by Orthosoft, Inc. dba Zimmer CAS. Reason: The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product.
Details
Source
Device Recall
External ID
Z-0721-2022
Action Date
2022-03-09
Status
Ongoing
Category
device
Product Description
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Lot/Code Info: Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1
Quantity Affected: 14 units US; 132 units OUS
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-07
Company
Montreal
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 130 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Orthosoft, Inc. dba Zimmer CAS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Orthosoft, Inc. dba Zimmer CAS have FDA actions?
This is the only FDA action we have on record for Orthosoft, Inc. dba Zimmer CAS in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0721-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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