Stryker recalls Break-Away Femoral Nozzle (Product #0206-512-000) due to higher bioburden levels risking infection during orthopedic surgery. Affected units sold with Lot Number 17279012.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Stryker is recalling Break-Away Femoral Nozzles used in orthopedic procedures because they may not be sterile enough, increasing infection risk during surgery. This affects specific product models sold with Lot Number 17279012.
The nozzles were found to have higher bioburden levels than acceptable standards, meaning they may not be sterile enough for surgical use. This could lead to infections in patients during orthopedic procedures if the nozzles are used without proper sterilization.
Orthopedic surgeons and medical staff using the recalled Break-Away Femoral Nozzles for surgeries. Patients undergoing procedures with these nozzles are at risk of infection.
Check for Product Number 0206-512-000 and UDI (01)4546540039415 on the nozzle. Affected units were sold with Lot Number 17279012.
Look for Product Number 0206-512-000 and UDI (01)4546540039415 on the nozzle.
The nozzles were found to have higher bioburden levels than acceptable standards, which could lead to infections during surgery.
Check for Product Number 0206-512-000 and UDI (01)4546540039415. If you have the affected lot number, contact Stryker for guidance.
The recall is for infection risk during surgery, not direct injury. The hazard does not involve immediate physical harm like falls or fires.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1243-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1243-2018 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.
