Stryker recalls two models of femoral canal pressurizers due to higher than expected bioburden levels, potentially causing contamination. 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 two types of femoral canal pressurizers that may have higher than normal bioburden levels, increasing contamination risk during medical procedures. This could lead to infections or other complications for patients.
The pressurizers may have higher than acceptable levels of microorganisms, which could lead to contamination during medical procedures. This increases the risk of infections or complications for patients undergoing surgery.
Healthcare professionals using these devices for orthopedic procedures are most at risk. Patients receiving surgery with these devices may face infection risks.
Check for product numbers 0206-546-000 (medium, blue) or 0206-547-000 (large, red). Lot numbers 17276012 (medium) or 17282012 (large) are also associated with these models.
Identify the product number and lot number to confirm if your device is affected.
The recall is due to higher than expected bioburden levels, which could increase contamination risk during medical procedures.
Check the product number and lot number to see if your device is affected. If it is, contact Stryker for further instructions.
The recall addresses potential contamination risk, not direct injury. Serious injury is not mentioned in the recall.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1245-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1245-2018 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.
