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.
Recall
- Recall Number
- Z-0287-2024
- Event Number
- 93140
- Firm
- Stryker Corporation
- FEI Number
- 2936485
- Product Code
- KDD
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- September 13, 2023
- Posted
- November 9, 2023
- Address
- 5900 Optical Ct, San Jose, CA, 95138-1400
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.
Expired product distributed
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.
US: NH, TX, NY, NJ, OH, MN OUS: None
19 kits