Recall Z-1133-2023— Conformis, Inc.

Name: FDA recall Z-1133-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-14

Class II · Ongoing

Class II FDA medical device recall by Conformis, Inc., initiated 2022-11-14. FDA's recall record names no specific 510(k) clearance for this event. Product: iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE. Reason: 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..

Recalling firm: Conformis, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-11-14
Firm location: Billerica, MA, United States

Product description

iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.