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.
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 3/5 (High).
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.
See all 13 products in this recall →Related recalls
Same manufacturer · Stryker Instruments Div. of Stryker Corporation
See all →- HighStryker Triton Canister Scanning Labels Recalled Due to Color Variance
FDA (Devices) · 2022-07-27
- ModerateTriton Sponge System Software Instructions Updated for Proper Sponge Handling
FDA (Devices) · 2022-07-27
- HighSurgiCount+ System software error bypasses sponge tracking alerts
FDA (Devices) · 2022-07-27
- SevereStryker Recalls Cranial Perforators Due to Potential Metal Fragment Risk
FDA (Devices) · 2020-11-18
- ModerateStryker Neptune E-SEP Blade Electrode Recalled for Expired Product
FDA (Devices) · 2020-05-06
Same hazard · infection
See all →- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateStryker Recalls Sagittal Blades Due to Potential Sterile Barrier Breach
FDA (Devices) · 2016-10-26
- HighStryker Humerus End Cap Recall Due to Compromised Sterility
FDA (Devices) · 2020-06-24
- HighSynthes Opal Intervertebral Cage Spinal Implant Recall: Sterility Not Confirmed
FDA (Devices) · 2024-03-13
- HighStryker Locking Screw Recall Due to Compromised Sterility
FDA (Devices) · 2020-06-24
- ModerateStryker 5.0mm Egg Bur Recall Due to Missing Notches
FDA (Devices) · 2014-06-18
- HighSklar Instruments Sterile Surgical Kits Recalled for Packaging Defects
FDA (Devices) · 2025-01-22