Zavation recalls 10 gauge orthopedic stylets with potential sterilization issues. Affected products may not be properly sterilized, risking infection during spinal procedures.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling 10-gauge orthopedic stylets used in spinal procedures because some may not have been properly sterilized. This could lead to infections during surgery if the device is used without adequate sterilization.
The recalled stylets may not have been adequately sterilized, meaning they could carry harmful bacteria or contaminants. If used during surgery without proper sterilization, this could lead to infections in patients.
Orthopedic and spinal surgery patients and medical professionals who use the recalled stylets. The risk is primarily for those undergoing procedures requiring these devices.
Check for the product code INTVM-DSSKBD on the device. Affected batches are 19102741, 200127, and 2001246. These stylets are used in orthopedic and spinal procedures.
Look for the product code INTVM-DSSKBD and batch numbers 19102741, 200127, or 2001246 on the device.
The recall indicates some may not have been properly sterilized, so they should not be used until the manufacturer confirms safety.
Check the device label for the product code and batch numbers. If you have the affected batches, contact Zavation for instructions.
The recalled stylets have the product code INTVM-DSSKBD and batch numbers 19102741, 200127, or 2001246. They are used in orthopedic and spinal procedures.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1700-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1700-2021 from Zavation. 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.
