Stryker recalls InterPulse handpieces with higher-than-expected bioburden levels that may compromise sterility during orthopedic surgery.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Stryker is recalling several InterPulse handpieces used in orthopedic surgery because they have higher-than-expected bioburden levels. This could mean the devices aren't sterile enough for surgical use, potentially leading to infections in patients.
The handpieces have higher-than-acceptable bioburden levels, meaning they contain more bacteria than the manufacturer intended. This could lead to infections during surgery if the devices aren't properly sterilized.
Orthopedic surgeons and their patients who use the recalled InterPulse handpieces for surgery are most at risk. The specific models and lot numbers are listed in the recall notice.
Check for the product numbers: 0210-110-100, 0210-114-100, 0210-118-200, or 0210-218-000. Look for the specific lot numbers listed in the recall notice for each model.
Identify the product number and lot number on your handpiece to confirm if it's in the recall list.
The recall states the handpieces have higher-than-acceptable bioburden levels, which could compromise sterility during surgery. They are not safe for use until the recall is addressed.
Check the product number (0210-110-100, 0210-114-100, 0210-118-200, or 0210-218-000) and lot number against the list provided in the recall notice.
The recall does not specify a remedy, so contact Stryker directly to get guidance on next steps.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1246-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1246-2018 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.
