Zavation recalls orthopedic bone access kits with possible inadequate sterilization. Affected kits may pose infection risk during spinal or joint surgery.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling orthopedic bone access kits that may not have been properly sterilized. This could lead to infections during spinal or joint surgeries if used.
The kits may not have been adequately sterilized, which could lead to infections during surgery. This is a risk for patients undergoing spinal or joint procedures.
Orthopedic and spinal surgery patients who use the recalled kits. Surgeons and hospitals using these kits for procedures are most at risk.
Check for the model name 'ZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula' and the reference number VCF-DDSKbd. Kits sold with lot numbers 19113043 or 20041107 are affected.
Identify the product name and reference number to confirm if it matches the recalled items.
The kits may not have been adequately sterilized, which could lead to infections during spinal or joint surgeries.
The official recall notice does not specify a remedy or action steps for affected kits.
Lot numbers 19113043 and 20041107 are affected.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1707-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1707-2021 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.
