Zavation recalls 10-gauge orthopedic stylets with potential sterilization issues. Affected items 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 if used in medical procedures.
The recalled stylets may not have been adequately sterilized, meaning they could carry harmful bacteria or pathogens. If used in spinal or orthopedic procedures, 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 instruments.
Check for the model code INTVM-DSSKbd on the product. The affected lots are 2001246, 19102741, and 200127. These stylets are used in spinal and orthopedic procedures.
Look for the lot numbers 2001246, 19102741, or 200127 on the stylet packaging.
The recall states that products distributed as sterile may not have been adequately sterilized, so they are not safe for use in medical procedures.
Check the lot numbers on the product. If it matches the affected lots, contact Zavation for instructions.
Look for the model code INTVM-DSSKbd and the lot numbers 2001246, 19102741, or 200127 on the product.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1714-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1714-2021 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.
