Zav: Zavation recalls 11 gauge bipedicular bone access kits with drill (REF VCF-DDBAK-11) due to potential inadequate sterilization. Affected units sold in orthopedic/spinal procedures.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling a specific bone surgery kit for potential inadequate sterilization. This could lead to infections or other health risks if used without proper sterilization.
The kit may not have been properly sterilized, which could lead to infections or other health complications during surgery. This is a risk in medical procedures where sterility is critical.
Orthopedic and spinal surgery patients who received this specific bone access kit. Surgeons using the kit for procedures are most at risk.
Check for the model number REF VCF-DDBAK-11 on the kit. The kit was sold for orthopedic and spinal procedures and includes a drill. Lot numbers 19123262 and 20071774 are affected.
Look for the model number REF VCF-DDBAK-11 and lot numbers 19123262 or 20071774 on the kit.
The recall states products may not have been adequately sterilized, so it is not safe to use without checking the recall details.
Check the model number and lot numbers; if they match the recalled items, stop using it and contact Zavation for instructions.
Look for the model number REF VCF-DDBAK-11 and lot numbers 19123262 or 20071774 on the kit.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1713-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1713-2021 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.
