Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly o
FDA device recall Z-1976-2013 · posted 2013-08-22 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- Reason for recall
- Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KWP
- Quantity affected
- 1536 units (US) 880 (Foreign)
- Distribution
- Nationwide Distribution.
- Date initiated
- 2013-05-30
- Date posted
- 2013-08-22
- Date terminated
- 2014-12-30
- Location
- Allendale, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO: OASYS SYSTEM (K093670) | Stryker Spine | 2010-03-18 |