Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
iTotal Identity Impactor Handle Recalled by Conformis, Inc. Due to Loctite thread locker (epoxy) may not have been...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Conformis, Inc. directly.
Affected Products
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Quantity: 70
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Conformis, Inc.
Conformis, Inc. has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report