—#203530

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.

FDA product code: KDD — Kit, Surgical Instrument, Disposable
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot # 007047/UDI: 07613252632863

Why it was recalled

Expired product distributed

Root cause (FDA determination)

Process control

Action the firm took

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 endocustomersupport@stryker.com to arrange for product return. 5. If no product is found, complete acknowledgement form and return it back to Stryker.

Recalling firm

Firm: Stryker Corporation
Address: 5900 Optical Ct, San Jose, California 95138-1400

Distribution

Distribution pattern: US: NH, TX, NY, NJ, OH, MN OUS: None

Timeline

Recall initiated: 2023-09-13
Posted by FDA: 2023-11-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203530. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.