Stryker recalls 180-gram cement cartridges with higher bioburden levels than safe limits for orthopedic surgery. Affected units may cause infections if used without proper sterilization.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Stryker is recalling 180-gram cement cartridges used in orthopedic surgery because they contain higher levels of bacteria than safe limits. This could lead to infections if the cartridges are not properly sterilized before use.
The cartridges have higher than acceptable levels of bacteria (bioburden) which could contaminate surgical implants. If not properly sterilized before use, this may lead to infections in patients during surgery.
Orthopedic surgeons and medical facilities using the recalled cartridges for joint surgeries. Patients receiving procedures with these cartridges are at risk of infection.
Check for product number 0206-530-000 and lot numbers 17277012 or 17283012. The unique device identifier (UDI) is (01)4546540857880.
Verify the product number (0206-530-000) and lot numbers (17277012, 17283012) on the cartridge.
The cartridges have higher than acceptable levels of bacteria (bioburden) which could lead to infections if not properly sterilized before use.
Check the product number and lot numbers to see if it's affected. If it is, contact Stryker for guidance.
The recall addresses potential infection risk, not immediate physical injury. The hazard level is low risk.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1244-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1244-2018 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.
