This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contain
Summary
The FDA issued a Class II for This product is a single use sterile device that is used to direct the lesion to by Stryker Corporation. Reason: Expired Products distributed to customers.
Details
Source
Device Recall
External ID
Z-2261-2024
Action Date
2024-07-10
Status
Ongoing
Category
device
Product Description
This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contains a stylet that is removed once the cannula is placed. The electrode is then inserted into the cannula. Catalog Number: 0406-630-225
Lot/Code Info: GTIN: 07613327118438 Lot Number: 1000388946
Quantity Affected: 8 units
Reason for Recall
Expired Products distributed to customers
Distribution
US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-03
Company
Portage, MI
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 147 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker Corporation has 98 FDA actions in our database, including 90 recalls and 8 clearances.
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 (Stryker Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Corporation have FDA actions?
Stryker Corporation has 98 FDA actions in our database, including 90 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2261-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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