Stryker Recalls iVAS System Kits Due to Sterility Assurance Issues
Stryker is recalling 51 iVAS System Kits for spinal orthopedic use because bioburden levels were found to be higher than acceptable rates, posing a risk of infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of sterility assurance in a medical device, which carries a significant risk of infection or serious injury.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 51 units of the 10g/15mm (15/2) iVAS System Kit, Product Number 0705-115-000, intended for spinal orthopedic use. The recall is being conducted because bioburden levels were found to be higher than internal acceptable rates, indicating a lack of sterility assurance.
The affected products, identified by Lot Number 17283012 and UDI (01)7613252029830, were distributed in all 50 U.S. States and the District of Columbia. They were also distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and the United Kingdom.
Healthcare providers and facilities should stop using the affected kits and contact Stryker for further instructions. Patients who have received these kits should consult their healthcare provider regarding potential risks associated with the lack of sterility assurance.
The recalled product
- Product
- 10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use.
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 51
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 (1)
- Lot Number: 17283012 UDI: (01)7613252029830
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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