Z-1133-2023Class II

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

Name: Z-1133-2023 iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Creator: Conformis, Inc.
Published: 2022-11-14
License: https://open.fda.gov/license/

ConforMIS, Inc. / initiated 2022-11-14 / Open, Classified / root cause: manufacturing process

FDA source

Conformis, Inc. began a recall of iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE on 2022-11-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1133-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-14
Posted: 2023-02-13
Recalling firm: ConforMIS, Inc.
Product: iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Product code: OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: UDI-DI 00810933030582 Lot D221301

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1133-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1133-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-13

Product code OIY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)