Stryker recalls specific spinal orthopedic kits due to higher bioburden levels than acceptable, risking infection. Affected kits have product number 0506-485-000 and UDI (01)4546540907035.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Stryker is recalling a specific spinal orthopedic kit because it may not be sterile enough, which could lead to infections. This affects medical professionals using the kit for spinal procedures.
The kit may contain higher levels of bacteria than safe limits, which can cause infections during surgery. This happens because the manufacturing process did not meet sterility standards.
Medical professionals who use this specific spinal orthopedic kit for procedures are likely affected. Patients undergoing surgery with this kit could be at risk of infection.
Check for product number 0506-485-000 and unique device identifier (UDI) (01)4546540907035 on the kit packaging. The kit is used for spinal orthopedic procedures.
Look for product number 0506-485-000 and UDI (01)4546540907035 on the kit packaging.
The kit may not be sterile enough due to higher bioburden levels than acceptable, which could lead to infections during surgery.
The recall record does not specify a remedy, so contact Stryker directly for guidance.
The recall indicates the kit may not be sterile enough, so it should not be used until the manufacturer provides instructions.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1249-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1249-2018 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.
