Z-1976-2013 Class I Terminated
FDA device recall Z-1976-2013 was initiated by Stryker Spine on May 30, 2013 and is designated Class I. 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. The recall status is terminated (terminated December 30, 2014). Affected quantity: 1536 units (US) 880 (Foreign).
Recall Details
- Product Type
- Devices
- Report Date
- August 28, 2013
- Initiation Date
- May 30, 2013
- Termination Date
- December 30, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1536 units (US) 880 (Foreign)
Product Description
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.
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 Pattern
Nationwide Distribution.
Code Information
K093670 Catalog numbers: Small - 48551044 Medium - 48551045 Large - 48551046 Large Long - 48551047 Mini- 48551048 All lots of the above