Conformis recalls iTotal Identity Impactor Handle Model 1080-212/ED-07827 REV AE due to risk of screw falling into patient during procedures. Affected units have specific model and lot numbers.
Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absence of epoxy, the screw may loosen and fall into the patient during a procedure.
Conformis is recalling a dental handpiece handle because the screw might loosen and fall into a patient during dental procedures. This could cause injury if the screw enters the patient's mouth or throat.
The handle's screw may loosen because the Loctite thread locker (epoxy) wasn't properly applied. If the screw falls during a dental procedure, it could enter the patient's mouth or throat, causing injury.
Dental professionals using the iTotal Identity Impactor Handle model 108:212/ED-07827 REV AE are most at risk. Patients undergoing dental procedures with this handle could be affected if the screw falls into their mouth.
Check for the model number 1080-212/ED-07827 REV AE on the handle. The lot number D221301 is also associated with this recall. This handle is used in dental procedures.
Look for the model number 1080-212/ED-07827 REV AE on the handle.
Contact Conformis Inc. for further assistance with the recall.
The recall is because the Loctite thread locker (epoxy) may not have been applied to the screw, which could loosen and fall into the patient during a dental procedure.
Check for the model number 1080-212/ED-07827 REV AE and lot number D221301 on the handle.
Contact Conformis Inc. for further assistance with the recall.
We’ve drafted a message you can send Conformis to request your refund or repair — edit it as you like.
Subject: Recall Z-1133-2023 — Conformis Conformis Hello, I own a Conformis that is covered by recall Z-1133-2023 from Conformis. 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.
