Stryker iVAS System Kits Recalled for Sterility Assurance Issues
Stryker is recalling 504 iVAS System Kits for spinal orthopedic use because bioburden levels were found to be higher than internal acceptable rates, indicating a lack of sterility assurance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a lack of sterility assurance (bioburden), which poses a risk of infection, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 504 units of the 11g/10mm and 11g/15mm iVAS System Kits. These medical devices are intended for spinal orthopedic use. The specific product numbers are 0705-310-000 and 0705-315-000.
The recall was initiated due to a lack of sterility assurance. Bioburden levels in the affected kits were found to be higher than the manufacturer's internal acceptable rates. The affected lots include Lot Number 17277012 (12-month shelf life) and Lot Numbers 17283012 and 17299012 (36-month shelf life).
The products were distributed in all 50 U.S. states and the District of Columbia, as well as in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, the Netherlands, and the United Kingdom. Healthcare facilities and distributors should stop using these products and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- 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
- Affected units
- 504
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 1. Shelf Life: 12 months
- Lot Number: 17277012
- 2. Shelf Life: 36 months
- Lot Numbers: 17283012
- 17299012 UDI: (01)7613252505983
- (01)7613252505969
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 13 recalled by Stryker Instruments Div. of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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