Stryker recalls orthopedic cement kits with higher bioburden levels than safe limits. Affected kits may cause infections if used without proper sterility.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Stryker is recalling certain orthopedic cement mixing kits due to higher than acceptable bioburden levels. This could lead to infections if the kits are used without proper sterility.
The kits contain higher levels of microorganisms than the manufacturer's acceptable limits. This could lead to infections if the kits are not properly sterilized before use.
Orthopedic surgeons and medical staff who use the recalled cement kits for surgeries. Those using the kits without proper sterilization procedures are at higher risk.
Check for product number 0306-573-000 and lot numbers 17282012, 17283012, 17297012, or 17298012. The kits are for orthopedic use and have a unique identifier (UDI) of (01)4546540055415.
Verify the product number and lot numbers listed in the recall notice to confirm if your kit is affected.
The kits have higher bioburden levels than the manufacturer's acceptable limits, which could lead to infections if not properly sterilized.
Check the product number and lot numbers to see if your kit is affected. If it is, contact Stryker for further instructions.
The recall is due to potential infection risk from improper sterility, not direct injury risks like cuts 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-1248-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1248-2018 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.
