Zavation recalls 10-gauge cement delivery cannula kits for spinal procedures due to potential inadequate sterilization. Affected lots: 2003661, 19113051, 20071709, 20071843.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling specific spinal surgery kits that may not have been properly sterilized. This could lead to infections or other complications if used in procedures.
The kits may not have been adequately sterilized, which could lead to infections or other complications during surgery. This is a potential risk if the kits are used without proper sterilization.
Orthopedic and spinal surgery patients who received the recalled kits. Surgeons using these kits for procedures are most at risk.
Check for the model number REF VCG-SCDK on the kit. Affected lots include 2003661, 19113051, 20071709, and 20071843.
Look for the lot numbers 2003661, 19113051, 20071709, or 20071843 on the kit packaging.
The kits may not have been adequately sterilized, which could lead to infections or complications during surgery.
Check the lot number on the kit packaging. If it matches the affected lots, contact Zavation for instructions.
The recall is due to potential inadequate sterilization, which could lead to infections, but not immediate serious injury in normal use.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1709-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1709-2021 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.
