CLASS II ONGOING Device recall · Reported 22 Feb 2023 · FDA Enforcement Report

iTotal Identity Impactor Handle recalled by Conformis

Conformis is recalling iTotal Identity Impactor Handle, distributed nationwide in the US. The recall was initiated on 14 Nov 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI 00810933030582 Lot D221301

Quantity recalled70

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1133-2023
FDA event ID: 91376
Recalling firm: Conformis, Billerica, MA
Classification: Class II
Status: Ongoing
Recall initiated: 14 Nov 2022
FDA classified: 13 Feb 2023
Reported: 22 Feb 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

14 Nov 2022	Recall initiated by company
13 Feb 2023	Classified by FDA	+91 days
22 Feb 2023	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Alabama Arizona Colorado Florida Georgia Kansas Kentucky Louisiana Massachusetts Maryland Mississippi Nebraska New Hampshire Nevada New York Ohio Tennessee Wisconsin Wyoming

Questions about this recall

Why was it 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.

Which lots are affected?

UDI-DI 00810933030582 Lot D221301

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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23 Apr 2025Device	CLASS II	restor3d Cordera Hip System recalled by Conformis	Conformis	Labeling Errors	Nationwide
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23 Aug 2023Device	CLASS II	Hip-screw-, Sterile Eo recalled by Conformis	Conformis	Other	Nationwide
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2 Dec 2020Device	CLASS II	iTotal Hip Replacement System recalled by Conformis	Conformis	Other	CA

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