Zavation recalls specific bone access kits for orthopedic procedures due to potential inadequate sterilization. Affected kits may pose infection risks if used without proper sterilization.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling certain bone access kits for orthopedic procedures because some may not have been properly sterilized. Using these kits without adequate sterilization could lead to infections.
The kits 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 conditions are critical.
Orthopedic and spinal surgery patients who use the recalled kits. Surgeons and medical staff handling these kits are most at risk.
Check for the model number REF VCF-DSBAK on the kit. The kits were sold with specific lot numbers: 19113041, 20071853, 20071714, and 2003803.
Look for the lot numbers 19113041, 20071853, 20071714, or 2003803 on the kit packaging.
The recall states that products distributed as sterile may not have been adequately sterilized, so they are not safe for use without proper sterilization.
The recall does not specify a remedy, so the official notice does not provide instructions on what to do with the kit.
Check the kit for the model number REF VCF-DSBAK and the lot numbers 19113041, 20071853, 20071714, or 2003803.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1708-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1708-2021 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.
