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.
- Company
- Stryker Spine
- Recall Initiated
- May 30, 2013
- Posted
- August 22, 2013
- Terminated
- December 30, 2014
- Recall Number
- Z-1976-2013
- Quantity
- 1536 units (US) 880 (Foreign)
- Firm Location
- Allendale, NJ
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.
Distribution
Nationwide Distribution.
Lot / Code Info
K093670 Catalog numbers: Small - 48551044 Medium - 48551045 Large - 48551046 Large Long - 48551047 Mini- 48551048 All lots of the above
Root Cause
Other
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.