Stryker, REF: CAT00241, Portal Entry Kit consisting of a… recallZ-0287-2024 · Stryker Corporation · initiated Sep 13, 2023
Open, Classified
Is my device affected?
- 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.
- 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.
- 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 product distributed
FDA root cause category: Process control
What the company is doing
On 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 [email protected] to arrange for product return. 5. If no product is found, complete acknowledgement form and return it back to Stryker.
Recall details
- Recall number
- Z-0287-2024
- Status
- Open, Classified
- Initiated by the company
- Sep 13, 2023
- Posted by the FDA
- Nov 9, 2023
- Recalling firm
- Stryker Corporation
- Quantity
- 19 kits
- Product code
- KDD
- Distribution
- US: NH, TX, NY, NJ, OH, MN OUS: None
Product description
Stryker, 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 (models, lots, serial numbers)
Lot # 007047/UDI: 07613252632863
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA CAT00241Stryker Corporation · KIT, SURGICAL INSTRUMENT, DISPOSABLE1 recall6 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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