Use cautionMedical device recall · FDA · Published November 14, 2022
Conformis iTotal Identity Impactor Handle Recall: Screw May Fall During Procedure
Conformis recalls iTotal Identity Impactor Handle Model 1080-212/ED-07827 REV AE due to risk of screw falling into patient during procedures. Affected units have specific model and lot numbers.
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.
Take action
Contact the company
📍Recalling firmConformis, Inc.600 Technology Park Dr Ste 3 · Billerica, MA 01821-4154
“Conformis iTotal Identity Impactor Handle Recall: Screw May Fall During Procedure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59375-conformis-itotal-identity-impactor-handle-recall-screw-may-fall-during. Based on FDA recall #Z-1133-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1133-2023%22&limit=1).
Conformis Inc. recalled the iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE, due to a potential screw loosening hazard that could fall into a patient during surgery. The Food and Drug Administration announced the voluntary Class II recall on November 14, 2022.
How to tell if you have it
Brand: Conformis
Product: iTotal Identity Impactor Handle
Model No.: 1080-212/ED-07827 REV AE
UDI-DI: 00810933030582
Lot: D221301
Quantity: 70 units
The hazard
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.
Context
GovInfoNow's records show Conformis Inc. has had 14 other recalls on record since July 24, 2017. Other recent recalls include a hip system acetabular liner recalled for incorrect labeling on March 25, 2025, and an Identity Imprint PS Tibial Tray packaging mix-up reported on March 11, 2024.
How to tell if you have this one
Check for the model number 1080-212/ED-07827 REV AE on the handle. The lot number D221301 is also associated with this recall. This handle is used in dental procedures.
Brand
Conformis
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Handle Model
Look for the model number 1080-212/ED-07827 REV AE on the handle.
Contact Manufacturer
Contact Conformis Inc. for further assistance with the recall.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 19 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Colorado, Florida, Georgia, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Mississippi, Nebraska, Nevada, New Hampshire, New York, Ohio, Tennessee, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1133-2023 (November 14, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1133-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.