Stryker recalls 10g/15mm iVAS System Kit (Product #0705-115-000) due to higher bioburden levels risking infection during spinal surgery. Affected units sold with Lot #17283012.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Stryker is recalling a specific spinal surgery kit because it may not be sterile enough, which could lead to infections during procedures. This affects medical devices used in spinal orthopedic surgeries.
The kit may contain higher levels of bacteria than safe limits, which could cause infections during spinal surgery. This happens because the sterilization process didn't meet the required standards.
Healthcare professionals using this kit for spinal surgery are most at risk. Patients undergoing procedures with this kit could face infection risks.
Check for Product Number 0705-115-000 and UDI (01)7613252029830 on the kit. The kit was sold with Lot Number 17283012 for spinal orthopedic use.
Look for Product Number 0705-115-000 and UDI (01)7613252029830 on the kit label.
The recall states the kit may not be sterile enough, so it should not be used until the manufacturer confirms it's safe.
The recall does not specify a remedy, so contact Stryker directly for guidance.
Check for Product Number 0705-115-000 and UDI (01)7613252029830 on the kit label.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1253-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1253-2018 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
