Stryker recalls 11g Verteport Cement Cannulas (18/pkg) for spinal surgery due to higher bioburden levels risking infection. Affected units have Product Number 0306-511-000 and UDI (01)7613252594307.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Stryker is recalling 11g Verteport Cement Cannulas used in spinal surgery because they may not be sterile enough. This could lead to infections during surgery if the cannulas are used without proper sterility.
The cannulas were found to have higher bioburden levels than acceptable limits, meaning they might not be sterile. This could lead to infections during spinal surgery if the cannulas are used without proper sterilization.
Healthcare professionals using these cannulas for spinal orthopedic procedures are affected. Patients undergoing surgery with these cannulas face a small risk of infection.
Check for Product Number 0306-511-000 and UDI (01)7613252594307 on the packaging. These cannulas were sold for spinal orthopedic use in the U.S.
Look for Product Number 0306-511-000 and UDI (01)7613252594307 on the packaging.
The recall is due to higher bioburden levels than acceptable limits, which could mean the cannulas are not sterile enough for spinal surgery.
The official recall notice does not specify a remedy or action for affected products.
The recall addresses potential infection risk, not direct injury. The hazard is not described as causing serious injury in normal use.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1247-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1247-2018 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.