Zavation recalls 10-gauge cement delivery sets with specific lot numbers for orthopedic/spinal procedures due to potential inadequate sterilization.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling 10-gauge cement delivery sets 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 the products are used without proper sterilization.
The products may not have been adequately sterilized, which could lead to infections or other health risks if used in medical procedures. This is a potential hazard for sterile medical devices that come into contact with the body.
Healthcare professionals using Zavation's 10-gauge cement delivery sets for orthopedic or spinal procedures are most at risk. Patients receiving these procedures may also be affected if the products are not properly sterilized.
Check the product code (INTVM-SCDK) and lot numbers: 20051290, 20081943, 20061420, 2002439. These sets are used in orthopedic or spinal procedures and are sold for medical use.
Look for lot numbers 20051290, 20081943, 20061420, or 2002439 on the product.
The products may not have been adequately sterilized, which could lead to infections or other health risks if used in medical procedures.
The recall does not specify a remedy, so contact Zavation directly for guidance.
Yes, check lot numbers 20051290, 20081943, 20061420, and 2002439.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1720-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1720-2021 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.
