Recall Z-2260-2024 ยท OAR Injector, Vertebroplasty (Does Not Contain Cement)
Stryker Corporation
Curved, super elastic cement delivery needle that passes through the cannula in a straight configuration and enters the vertebral body in a curved configuration. This provides physicians with the ability to inject bone cement into multiple different areas through a single point of access in the patient. Catalog Number: 1025-011-500
| 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 | 3 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
This recall record lists no 510(k) number.