Devices

Device Recall Stryker iVAS Inflatable Vertebral Augmentation System

Model / Serial
1. Shelf Life: 12 months; Lot Number: 17277012; 2. Shelf Life: 36 months; Lot Numbers: 17283012, 17299012 UDI: (01)7613252505983; (01)7613252505969
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
No
Distribution
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.
Product Description
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.
Manufacturer
Stryker Instruments Div. of Stryker Corporation
1 Event
- Recall of Device Recall Stryker iVAS Inflatable Vertebral Augmentation System

Manufacturer

Stryker Instruments Div. of Stryker Corporation

Manufacturer Address
Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
Manufacturer Parent Company (2017)
Stryker
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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