Nakanishi recalls Micro Surgery Handpiece SGS-E2S models with outdated cleaning instructions. Users must replace old operation manuals with new ones to ensure safe sterilization.
Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous operation manuals associated with the SGS/SGA products must be replaced by new operation manuals.
Nakanishi is recalling Micro Surgery Handpiece SGS-E2S models due to outdated operation manuals that don't include updated cleaning and sterilization instructions. This could lead to improper sterilization if users follow old instructions.
The previous operation manuals provided incorrect cleaning and sterilization procedures. If users follow these outdated instructions, the handpieces might not be properly sterilized, increasing infection risk during dental procedures.
Dental professionals using the SGS-E2S handpieces with serial numbers listed in the recall. Those who have the older operation manuals are most at risk.
Check for serial numbers starting with 0LZ, 0BB, 0BC, 0BD, or other prefixes listed in the recall. The product is sold under the brand Nakanishi for dental implant procedures.
Remove and replace the previous operation manuals (OM-SH0015E002, OM-SH0015E003, etc.) with the new updated manuals.
The previous operation manuals had outdated cleaning and sterilization instructions. Updated manuals are required to ensure proper sterilization of the handpieces.
No, but you must replace the old operation manuals with the new ones to follow correct cleaning procedures.
Serial numbers starting with 0LZ00004-0LZ00013, 0LZ00015-0LZ0018, and other specific ranges listed in the recall.
We’ve drafted a message you can send Nakanishi to request your refund or repair — edit it as you like.
Subject: Recall Z-0224-2019 — Nakanishi Nakanishi Hello, I own a Nakanishi that is covered by recall Z-0224-2019 from Nakanishi. 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.
