iTotal Identity Impactor Handle, Model No.… recallZ-1133-2023 · Conformis, Inc. · initiated Nov 14, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Conformis, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process control
What the company is doing
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).
Recall details
- Recall number
- Z-1133-2023
- Status
- Open, Classified
- Initiated by the company
- Nov 14, 2022
- Posted by the FDA
- Feb 13, 2023
- Recalling firm
- Conformis, Inc.
- Quantity
- 70
- Product code
- OIY
- 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.
Product description
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Code information (models, lots, serial numbers)
UDI-DI 00810933030582 Lot D221301
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ITOTAL IDENTITY IMPACTOR HANDLE 1080-212Conformis, Inc. · Orthopedic Manual Surgical Instrument1 recall7 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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