Stryker Single Use Device (Stryker) – Expired Product (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Stryker Corporation
Lot Codes / Batch Numbers
GTIN: 07613327118438 Lot Number: 1000388946
Products Sold
GTIN: 07613327118438 Lot Number: 1000388946
Stryker Corporation is recalling This product is a single use sterile device that is used to direct the lesion to the targeted site. due to Expired Products distributed to customers. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Expired Products distributed to customers
Recommended Action
Per FDA guidance
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 Instruments.recalls@stryker.com, 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 Instruments.recalls@stryker.com with questions or concerns.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026