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

Recall number

Z-1133-2023

Recalling firm

Conformis, Inc.

Product

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

Status

Open, Classified

Initiated

2022-11-14

Posted

2023-02-13

Terminated

not on file

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.

Root cause

Process control

Action

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).

Quantity

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.

Lot, serial or model codes

UDI-DI 00810933030582 Lot D221301

510(k) numbers

not on file

PMA numbers

not on file

Product code

OIY

Firm FEI

3009844603

Firm city

Billerica

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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