Z-2261-2024Class II

This product is a single use sterile device that is used to direct the lesion to the targeted site. Each...

Name: Z-2261-2024 This product is a single use sterile device that is used to direct the lesion to the targeted site. Each...
Creator: Stryker Corporation
Published: 2024-06-03
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2024-06-03 / Open, Classified

FDA source

Stryker Corporation began a recall of 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... on 2024-06-03. FDA classified it as Class II and gives the reason as "Expired Products distributed to customers". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2261-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-03
Posted: 2024-07-03
Recalling firm: Stryker Corp.
Product: 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
Product code: GXI Probe, Radiofrequency Lesion
Reason for recall: Expired Products distributed to customers
FDA root cause: Storage
Action: Stryker issued Urgent Medical Device Recall Letter on 6/3/24 via Fed'X. Letter states reason for recall, health risk and action to take: Actions to be taken: 1. Immediately check your inventory to locate and quarantine any affected products found at your facility. 2. Sign and return the enclosed Business Response Form (BRF) by email to [email protected], even if affected product is no longer in your inventory. 3. Upon receipt of the completed BRF, a shipping label will be provided to return any recalled product on-hand and Stryker will arrange for replacement product(s) to be shipped promptly. 4. Maintain awareness of this communication internally and inform Stryker if any of the devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. Please contact Lacey Marshall at 269-270-5950 or [email protected] with questions or concerns.
Quantity in commerce: 8 units
Distribution: US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.
Product codes and lots: GTIN: 07613327118438 Lot Number: 1000388946

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2261-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2259-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-10	2024-07-03
Z-2260-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-10	2024-07-03
Z-2261-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-10	2024-07-03

Product code GXI

K032406Class IIStryker RF Electrodes and CannulaeStryker Instruments / cleared 2004-04-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)