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

FDA device recall Z-1133-2023 · posted 2023-02-13 · Open, Classified

Recall details

Recalling firm

Conformis, Inc.

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.

Action taken

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).

Root cause

Process control

Status

Open, Classified

Product code

OIY

Quantity affected

70

Distribution

US Nationwide distribution in the states of AL, AZ, CO, FL, GA, KS, KY, LA, MA, MD, MS, NE, NH, NV, NY, OH, TN, WI, WY.

Date initiated

2022-11-14

Date posted

2023-02-13

Location

Billerica, MA