Zavation recalls 10-gauge ZVplasty Direct Access Beveled Tip Trocars (REF VCF-1022) used in orthopedic/spinal procedures due to potential inadequate sterilization. Affected lots: 20071558, 19113038, 20102491, 20041108.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling 10-gauge ZVplasty Direct Access Beveled Tip Trocars (REF VCF-1022) used in orthopedic or spinal procedures because some products may not have been properly sterilized. This could lead to infections or other health risks if used in medical procedures.
The trocars may not have been adequately sterilized during manufacturing, which could lead to infections or other health complications if used in medical procedures. This is a potential risk for patients and healthcare providers during surgical operations.
Medical professionals who use these trocars for orthopedic or spinal procedures are most at risk. Patients undergoing surgery with these devices could be affected if the products were not properly sterilized.
Check for the model number REF VCF-1022 on the trocar packaging. Affected lots include 20071558, 19113038, 20102491, and 20041108.
Look for the lot numbers 20071558, 19113038, 20102491, or 20041108 on the trocar packaging.
The products may not have been adequately sterilized, which could lead to infections or other health risks during medical procedures.
Check the lot number on the packaging. If it matches the affected lots (20071558, 19113038, 20102491, 20041108), contact Zavation for further instructions.
The recall is due to potential inadequate sterilization, which could lead to infections, but the risk of serious injury is not specified in the notice.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1703-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1703-2021 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.