Stryker recalls Revolution 90 Degree Tibial Nozzle (Product Number 0606-516-000) due to higher bioburden levels than acceptable, risking infection during orthopedic surgery.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Stryker is recalling a specific orthopedic surgical nozzle because it may not be sterile enough, which could lead to infections during surgery. This affects surgeons and hospitals using the product.
The nozzle may have higher bioburden levels than acceptable, meaning it could contain more bacteria than intended. This poses a risk of infection during surgery if the product is not properly sterilized.
Surgeons and hospitals that use the Revolution 90 Degree Tibial Nozzle for orthopedic procedures are affected. The risk is primarily for medical professionals during surgical use.
Check for Product Number 0606-516-000 and UDI (01)4546540911971 on the nozzle. The recall applies to lot number 17293012.
Look for Product Number 0606-516-000 and UDI (01)4546540911971 on the nozzle.
The product may not be sterile enough, which could lead to infection during surgery. Do not use until the recall is addressed.
Check the product details to see if it's affected. If it is, contact Stryker for guidance.
Look for Product Number 0606-516-000 and UDI (01)4546540911971 on the nozzle. The recall applies to lot number 17293012.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1251-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1251-2018 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.
