Conformis, Inc. iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Brand
Conformis, Inc.
Lot Codes / Batch Numbers
UDI-DI 00810933030582 Lot D221301
Products Sold
UDI-DI 00810933030582 Lot D221301
Conformis, Inc. is recalling iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE due to 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 fal. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On November 14, 2022, the firm sent an Instrument care reminder to field reps, which included an Instrument handling and care reminder. The firm sent additional letters and emails to affected consignees starting January 17, 2023. Consignees were instructed to inspect their inventory for product from the affected lot. Immediately cease use of affected product and contact customer service if a field representative has not already reached out to you. Conformis will have a field representative come onsite to inspect, apply Loctite, and review techniques for inspecting the instrument. Customers were informed they may continue to use impactor handles from other lots. However, they should ensure they are properly connecting the impactor handle to the keel punch (Refer to surgical technique guide).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026