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This product is a single use sterile device that is used to… recallZ-2261-2024 · Stryker Corporation · initiated Jun 3, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Expired Products distributed to customers

FDA root cause category: Storage

What the company is doing

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.

Recall details

Recall number
Z-2261-2024
Status
Open, Classified
Initiated by the company
Jun 3, 2024
Posted by the FDA
Jul 3, 2024
Recalling firm
Stryker Corporation
Quantity
8 units
Product code
GXI
FDA submissions
K032406
Distribution
US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.

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

Code information (models, lots, serial numbers)

GTIN: 07613327118438 Lot Number: 1000388946

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 94755).

Sources and updates

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