Stryker recalls certain orthopedic Intramedullary Brushes due to higher bioburden levels than acceptable, risking contamination during surgery. Affected units have specific product numbers and lot numbers.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Stryker is recalling orthopedic Intramedullary Brushes with Product Number 6198-001-514 that may have higher bioburden levels than safe. This could lead to contamination during surgery if used without proper sterilization.
The brushes may contain higher levels of bacteria than allowed, which could lead to infections if not properly sterilized before use. This is a risk during surgical procedures where sterility is critical.
Orthopedic surgeons and medical staff who use the recalled brushes for procedures. Patients undergoing surgery with these brushes are at risk of contamination.
Check for Product Number 6198-001-514 and UDI (01)4546540255853 on the brush packaging. Lot Number 17284012 is also associated with this recall.
Verify the Product Number 6198-001-514 and UDI (01)4546540255853 on the brush packaging.
The brushes may have higher bioburden levels than acceptable, which could lead to contamination during surgery if not properly sterilized.
Check the Product Number and UDI on the packaging to see if it matches the recalled items. Contact Stryker for further instructions.
The recall is for potential contamination during surgery, not direct injury. However, improper sterilization could lead to infections.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1255-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1255-2018 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.
