Reported Feb 22, 2023 · Ongoing
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Conformis, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Conformis, Inc. · 600 Technology Park Dr Ste 3 · Billerica, MA · 01821-4154
Is this the product you have?
- iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
- Lot codes and dates
- UDI-DI 00810933030582 Lot D221301
- Amount recalled
- 70
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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