Zavation recalls ZVplasty Directional Cement Cannula (4 pieces per pack) with REF VCF-1080-S4 due to potential inadequate sterilization in orthopedic procedures.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling ZVplasty Directional Cement Cannula (4 pieces per pack) with reference number VCF-1080-S4 because these products may not have been properly sterilized. This could pose a risk during orthopedic or spinal procedures if the cannula is used without being fully sterile.
The products may not have been adequately sterilized, which could lead to infections or other complications during surgical procedures. This risk is specific to the sterile medical environment where the cannula is used.
Orthopedic and spinal surgery patients who use Zavation's ZVplasty Directional Cement Cannula (4 pieces per pack) with reference number VCF-1080-S4 are likely affected. Surgeons and medical staff using this product in procedures are at the highest risk.
Check for the product name 'ZVplasty Directional Cement Cannula' and reference number VCF-1080-S4. The product was distributed with lot number 20061366 for orthopedic and spinal procedures.
Look for the reference number VCF-1080-S4 on the packaging to confirm if the product is affected.
The recall states that products may not have been adequately sterilized, so it is not safe to use without confirming the reference number.
The recall does not specify a remedy, so you should check the reference number and contact Zavation for further instructions.
Check for the product name 'ZVplasty Directional Cement Cannula' and reference number VCF-1080-S4 with lot number 20061366.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1726-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1726-2021 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.