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.
- Company
- Stryker Corporation
- Recall Initiated
- September 13, 2023
- Posted
- November 9, 2023
- Recall Number
- Z-0287-2024
- Quantity
- 19 kits
- Firm Location
- San Jose, CA
Reason for Recall
Expired product distributed
Distribution
US: NH, TX, NY, NJ, OH, MN OUS: None
Lot / Code Info
Lot # 007047/UDI: 07613252632863
Root Cause
Process control
Action Taken
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.