Zavation recalls sterile cement mixing systems (INTV-MMS) used in orthopedic/spinal procedures due to potential inadequate sterilization. Affected lots: 2003787, 2001228.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling sterile cement mixing systems (INTV-MMS) used in orthopedic and spinal procedures because they may not have been properly sterilized. This could lead to infections or other complications during medical procedures.
The products may not have been adequately sterilized, which could lead to infections or other complications during medical procedures. This is a risk because sterile medical devices must meet strict cleaning and sterilization standards to prevent contamination.
Orthopedic and spinal surgery patients using Zavation's sterile cement mixing systems (INTV-MMS) are affected. Medical professionals who use these systems for procedures are most at risk.
Check for the model code INTV-MMS on the product. Affected lots are 2003787 and 2001228. These systems are used in orthopedic and spinal procedures.
Look for the lot numbers 2003787 or 2001228 on the cement mixing system.
The products may not have been adequately sterilized, which could lead to infections or other complications during medical procedures.
The recall record does not specify a remedy, so check the lot number and contact Zavation for further instructions.
Yes, these systems are used in orthopedic and spinal procedures.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1750-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1750-2021 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.
