Wright Medical recalls EVOLVE STEM 8.5MM Model 49:496S085 due to lack of sterility assurance. Affected units may pose infection risks during medical procedures.
Lack of sterility assurance
Wright Medical is recalling its EVOLVE STEM 8.5MM surgical device model 496S085 because it lacks proper sterility assurance. This could lead to infections if used in medical procedures without proper sterilization.
The device lacks sterility assurance, meaning it may not be properly sterilized before use. This could lead to infections during medical procedures if the device is used without adequate sterilization.
Surgical staff and patients using the EVOLVE STEM 8.5MM model 496S085 during medical procedures are at risk of infection if the device is not properly sterilized.
Check for the model number 496S085 on the device packaging or label. The product was sold with lot number 1668777.
Ensure the device is properly sterilized before use if it is part of the recalled model.
The recall indicates a lack of sterility assurance, so it may not be safe for medical procedures without proper sterilization.
Look for the model number 496S085 on the device packaging or label, and lot number 1668777.
The recall does not specify a remedy, so contact Wright Medical for guidance on safe use.
We’ve drafted a message you can send Wright Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2989-2020 — Wright Medical Wright Medical Hello, I own a Wright Medical that is covered by recall Z-2989-2020 from Wright Medical. 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.
