Z-0287-2024Class II

Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml...

Name: Z-0287-2024 Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml...
Creator: Stryker Corporation
Published: 2023-09-13
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2023-09-13 / Open, Classified / root cause: manufacturing process

FDA source

Stryker Corporation began a recall of 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... on 2023-09-13. FDA classified it as Class II and gives the reason as "Expired product distributed". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0287-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-13
Posted: 2023-11-09
Recalling firm: Stryker Corp.
Product: 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.
Product code: KDD Kit, Surgical Instrument, Disposable
Reason for recall: Expired product distributed
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 19 kits
Distribution: US: NH, TX, NY, NJ, OH, MN OUS: None
Product codes and lots: Lot # 007047/UDI: 07613252632863

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0287-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0287-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-09

Product code KDD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)