Zavation recalls 10-gauge cement delivery cannula kits for orthopedic procedures due to potential inadequate sterilization. Affected lots include 2003661, 19113051, 20071709, 20071843.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling specific orthopedic cement delivery kits that may not have been properly sterilized. This could lead to infections or other health risks if used in spinal or joint procedures.
The kits may not have been adequately sterilized during manufacturing, which could lead to infections or other health issues if used in surgical procedures. This is a risk specific to medical settings where sterile conditions are critical.
Orthopedic and spinal surgery patients who use the Zavation Unipedicular Cement Delivery Cannula Kit (10 Gauge, REF VCF-SCDK) with the listed lot numbers. Surgeons and medical staff handling these kits are most at risk.
Check the lot number on the kit: 2003661, 19113051, 20071709, or 20071843. The product is a 10-gauge cement delivery cannula kit for orthopedic or spinal procedures.
Look for the lot numbers 2003661, 19113051, 20071709, or 20071843 on the kit 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.
The recall does not specify a remedy, so contact Zavation directly for guidance.
Check the lot number on the kit: 2003661, 19113051, 20071709, or 20071843.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1721-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1721-2021 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.
