Zavation recalls OsteoFlex Cement and Mixing System (REF VCF-OSFL) due to potential inadequate sterilization. Affected lots include 13844ZV, 12320ZV, and others. Consumers should contact Zavation for details.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling OsteoFlex Cement and Mixing System (REF VCF-OSFL) because some units may not have been properly sterilized. This could lead to infections during orthopedic or spinal procedures if used without proper sterilization.
The products distributed as sterile may not have been adequately sterilized, which could lead to infections during medical procedures. This risk is specific to the product being used in orthopedic or spinal surgeries where sterility is critical.
Orthopedic and spinal surgery patients who use the OsteoFlex Cement and Mixing System (REF VCF-OSFL) with the listed lot numbers. Patients using the product without proper sterilization are at risk of infection.
Check the lot number on the product label. Affected lots include 13844ZV, 12320ZV, 14359ZV, 14171ZV, 13887ZV, 12670ZV, 11759ZV, 11850ZV, 13750ZV, 14273ZV, 14017ZV, 13665ZV, 12766ZV, 12037ZV, 14100ZV, 11693ZV, 14472ZV, 14388ZV, 13651ZV, and 13876ZV.
Look for the lot number on the product label to determine if it is affected.
The products distributed as sterile may not have been adequately sterilized, which could lead to infections during orthopedic or spinal procedures.
The recall record does not specify a remedy, so contact Zavation directly for instructions.
Affected lot numbers include 13844ZV, 12320ZV, 14359ZV, 14171ZV, 13887ZV, 12670ZV, 11759ZV, 11850ZV, 13750ZV, 14273ZV, 14017ZV, 13665ZV, 12766ZV, 12037ZV, 14100ZV, 11693ZV, 14472ZV, 14388ZV, 13651ZV, and 13876ZV.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1768-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1768-2021 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.
