Zavation recalls 10-gauge diamond tips used in spinal procedures due to potential inadequate sterilization. Affected lots from 2001200 production.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling 10-gauge diamond tips used in spinal procedures because some may not have been properly sterilized. This could lead to infections if used in medical procedures.
The tips may not have been adequately sterilized, which could lead to infections if used in medical procedures. This is a risk during surgical operations where sterile tools are critical.
Orthopedic and spinal surgery patients who used these specific diamond tips during procedures. Medical staff using the recalled items are most at risk.
Check for the model code INTVM-DWCd on the product. Affected lots include 11285ZV from the 2001200 production batch.
Look for the model code INTVM-DWCd on the product to confirm if it's affected.
The recall states that products distributed as sterile may not have been adequately sterilized, so they are not safe for use.
The recall does not specify a remedy, so you should check the product code and contact Zavation for further instructions.
Check for the model code INTVM-DWCd and lot number 11285ZV from the 2001200 production batch.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1716-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1716-2021 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.
