Recall Z-2261-2024 ยท GXI Probe, Radiofrequency Lesion
Stryker Corporation
This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contains a stylet that is removed once the cannula is placed. The electrode is then inserted into the cannula. Catalog Number: 0406-630-225
| Date | Jul 3, 2024 (initiated Jun 3, 2024) |
| Status | Open, Classified |
| Reason | Expired Products distributed to customers |
| Root cause | Storage |
| Action | Stryker issued Urgent Medical Device Recall Letter on 6/3/24 via Fed'X. Letter states reason for recall, health risk and action to take: Actions to be taken: 1. Immediately check your inventory to locate and quarantine any affected products found at your facility. 2. Sign and return the enclosed Business Response Form (BRF) by email to Instruments.recalls@stryker.com, even if affected product is no longer in your inventory. 3. Upon receipt of the completed BRF, a shipping label will be provided to return any recalled product on-hand and Stryker will arrange for replacement product(s) to be s |
| Quantity | 8 units |
| Distribution | US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032406 | STRYKER RF ELECTRODES AND CANNULAE Stryker Instruments, Apr 1, 2004 |