Stryker recalls two spinal orthopedic iVAS System Kits due to higher bioburden levels than acceptable, risking infection during surgery. Affected kits have specific product numbers and lot dates.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Stryker is recalling two types of iVAS System Kits used for spinal surgery because they may contain too many bacteria. This could lead to infections during procedures if the kits are used without proper sterilization.
The kits may have higher bacterial levels than the manufacturer's safety standards. This could cause infections during surgery if the kits are not properly sterilized before use.
Healthcare professionals using these kits for spinal procedures are most at risk. Patients undergoing surgery with the recalled kits could face infection.
Check for product numbers 0705-310-000 or 0705-315-000. Look for UDI codes (01)7613252505983 or (01)7613252505969. The kits were sold with shelf lives of 12 or 36 months.
Verify the product number and UDI code on the kit to confirm if it's affected.
The recall is due to higher bioburden levels than acceptable, which could lead to infections during surgery.
Check the product number and UDI code to confirm if it's affected. If it is, contact Stryker for further instructions.
Yes, patients undergoing surgery with the recalled kits could face infection risks if the kits are not properly sterilized.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1254-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1254-2018 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.
