Zavation recalls 10 gauge sterile stylets for orthopedic procedures due to potential inadequate sterilization. Affected items may not be safe for medical use.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling 10-gauge sterile stylets used in orthopedic and spinal procedures because they may not have been properly sterilized. This could lead to infections or other medical complications if used.
The stylets may not have been adequately sterilized, meaning they could carry harmful bacteria or other contaminants. If used during surgery, this could lead to infections or other complications for patients.
Medical professionals who use these stylets for orthopedic or spinal procedures are most at risk. Patients using the recalled items could face infection risks.
Look for the product name '10 GAUGE DIRECT UNILATERAL STYLET (1 X DIAMOND 1 X BEVEL) STERILE' on the packaging. These items were distributed for orthopedic and spinal procedures.
Verify the product name and model on the packaging to confirm if it matches the recalled items.
The products may not have been adequately sterilized, which could lead to infections or other complications if used in medical procedures.
The recall does not specify a remedy, so no immediate action is required beyond checking if you have the recalled product.
Look for the product name '10 GAUGE DIRECT UNILATERAL STYLET (1 X DIAMOND 1 X BEVEL) STERILE' on the packaging for orthopedic or 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-1749-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1749-2021 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.
