Zavation recalls sterile cement delivery kits for orthopedic procedures due to potential inadequate sterilization. Affected kits may pose infection risks if used.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling sterile cement delivery kits for spinal and orthopedic surgeries because they might not have been properly sterilized. Using these kits could lead to infections if they are not fully sterile.
The kits may not have been adequately sterilized, which could lead to infections if used in surgical procedures. Inadequate sterilization means the kits might contain harmful bacteria or other contaminants.
Orthopedic and spinal surgery patients who use the recalled cement delivery kits. Surgeons and medical staff handling these kits during procedures are most at risk.
Check for the model number 'ZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK' on the packaging. The affected lot number is 20081885.
Look for the model number 'ZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK' and lot number 20081885 on the packaging.
The recall applies to specific surgical kits used in orthopedic and spinal procedures. If you used the recalled model during surgery, contact your surgeon immediately.
Check for the model number 'ZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK' and lot number 20081885 on the packaging.
The recall does not specify a remedy, so contact Zavation directly for guidance on handling the kit.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1705-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1705-2021 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.
