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U.S. Department of Health and Human Services

Class 2 Device Recall Portal Entry Kit

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 Class 2 Device Recall Portal Entry Kitsee related information
Date Initiated by FirmSeptember 13, 2023
Date PostedNovember 09, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0287-2024
Recall Event ID 93140
Product Classification Kit, surgical instrument, disposable - Product Code KDD
ProductStryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Needles. Used to aid the surgeon in establishing arthroscopic portals and joint access.
Code Information Lot # 007047/UDI: 07613252632863
FEI Number 2936485
Recalling Firm/
Manufacturer		 Stryker Corporation
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information ContactAshley Lower
408-754-2000
Manufacturer Reason
for Recall		Expired product distributed
FDA Determined
Cause 2		Process control
ActionOn 09/27/2023, Stryker issued a "Urgent Medical Device Recall Notification" to affected consignees via mail. Stryker ask consignees to take the following actions: 1. Inform individuals within your organization who need to be aware of this device recall. 2. Check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your accounts. Response is required by November 30, 2023. 3. If affected product is found, quarantine and discontinue use of the recalled devices. 4. Please complete the response form on Appendix A of this notice and return devices back to Stryker Endoscopy. a. Please call Customer Service at 1-866-596-2022 or email endocustomersupport@stryker.com to arrange for product return. 5. If no product is found, complete acknowledgement form and return it back to Stryker.
Quantity in Commerce19 kits
DistributionUS: NH, TX, NY, NJ, OH, MN OUS: None
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.
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