Recall Z-0287-2024 ยท KDD Kit, Surgical Instrument, Disposable
Stryker Corporation
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.
| Date | Nov 9, 2023 (initiated Sep 13, 2023) |
| Status | Open, Classified |
| Reason | Expired product distributed |
| 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 |
| Quantity | 19 kits |
| Distribution | US: NH, TX, NY, NJ, OH, MN OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.