Device Recall Stryker iVAS Inflatable Vertebral Augmentation System

1. Shelf Life: 12 months; Lot Number: 17277012; 2. Shelf Life: 36 months; Lot Numbers: 17283012, 17299012   UDI: (01)7613252505983; (01)7613252505969

Orthopedic Devices

2

No

Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.

1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-000, UDI: (01)7613252505969 || for spinal orthopedic use.