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U.S. Department of Health and Human Services

Class 2 Device Recall RF Cannula

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 Class 2 Device Recall RF Cannulasee related information
Date Initiated by FirmJune 03, 2024
Date PostedJuly 03, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2261-2024
Recall Event ID 94755
510(K)NumberK032406 
Product Classification Probe, radiofrequency lesion - Product Code GXI
ProductThis 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 GTIN: 07613327118438 Lot Number: 1000388946
Recalling Firm/
Manufacturer		 Stryker Corporation
1941 Stryker Way
Portage MI 49002-9711
For Additional Information ContactSAME
269-800-1941
Manufacturer Reason
for Recall		Expired Products distributed to customers
FDA Determined
Cause 2		Storage
ActionStryker 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.
Quantity in Commerce8 units
DistributionUS Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GXI
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