Stryker recalls AutoPlex System bone cement products due to higher bioburden levels than acceptable, potentially causing contamination. Affected units include 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 certain AutoPlex System bone cement products because they contain higher levels of bacteria than safe limits. This could lead to infections or other complications during surgery. Affected products have specific product numbers and lot numbers listed in the recall notice.
The bone cement products have higher bioburden levels than the manufacturer's internal acceptable standards. This means there could be more bacteria present than intended, potentially leading to infections or other complications during surgical procedures.
Surgery patients and medical professionals using the recalled bone cement products. The risk is primarily for those undergoing procedures involving the recalled products.
Check for product numbers 0605-887-000 or 0607-687-000, and lot numbers 17278012, 17278022, 17279022, 17282012, 17282022, 17291012, or 17291022. The products are bone cement used in medical procedures.
Verify the product number and lot number on the packaging to determine if it is affected.
The bone cement has higher bioburden levels than the manufacturer's internal acceptable standards, which could lead to infections or complications during surgery.
Check for product numbers 0605-887-000 or 0607-687-000 and lot numbers 17278012, 17278022, 17279022, 17282012, 17282022, 17291012, or 17291022.
The recall notice does not specify a remedy, so contact Stryker directly for further instructions.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1250-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1250-2018 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.
