Recall Z-1976-2013 ยท KWP Appliance, Fixation, Spinal Interlaminal
Stryker Spine
Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.
| Date | Aug 22, 2013 (initiated May 30, 2013) |
| Status | Terminated |
| Reason | Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body. |
| Root cause | Other |
| Action | Stryker Spine sent a 'Urgent Medical Device Removal Letter'/'Customer Response Form' to Branch Managers, Agent Principals, Quality Contacts, Hospital OR Risk Managers, OR supervisor on 5/30/2013 via Fed Ex. Inventory should be examined and returned.The attached form should be completed and returned as well. Stryker Spine sent 'Urgent Medical Device Removal Letters' to Spinal Implant Surgeons on 6/20/2013 via Fed Ex. |
| Quantity | 1536 units (US) 880 (Foreign) |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093670 | MODIFICATION TO: OASYS SYSTEM Stryker Spine, Mar 18, 2010 |