Conformis iTotal CR Knee Replacement System Recall: Incorrect Patient Labels
Conformis recalls iTotal CR Total Knee Replacement Systems with incorrect patient ID labels and components. This could lead to wrong patient matches during surgery. Affected units have specific model numbers and serial numbers.
Lower-risk recall
The kits were prepared with incorrect patient ID labels and may contain incorrect components.
Contact the company
What happened, in plain English
Conformis is recalling certain iTotal CR Total Knee Replacement Systems because they were prepared with incorrect patient ID labels and may contain wrong components. This could cause wrong patients to receive the wrong implants during surgery. Read more at govinfonow.com/recall/69394-conformis-itotal-cr-knee-replacement-system-recall-incorrect-patient-labels.
Source Summary by GovInfoNow · govinfonow.com/recall/69394-conformis-itotal-cr-knee-replacement-system-recall-incorrect-patient-labels · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1108-2019
Cite this page
“Conformis iTotal CR Knee Replacement System Recall: Incorrect Patient Labels.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69394-conformis-itotal-cr-knee-replacement-system-recall-incorrect-patient-labels. Based on FDA recall #Z-1108-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1108-2019%22&limit=1).
Why it’s dangerous
The kits were prepared with incorrect patient ID labels, which means the wrong patient might be matched with the wrong implant during surgery. This could lead to incorrect implant placement and potential complications for the patient.
Who’s affected
Patients who received the recalled iTotal CR Total Knee Replacement Systems with model numbers TCR-121-1111-010102 and serial numbers 0432428 or 0432212 are affected. Surgeons and medical facilities using these specific units are at risk.
How to tell if you have this one
Check for model number TCR-121-1111-010102 and serial numbers 0432428 or 0432212 on the product packaging or documentation. The product is used for total knee replacements in patients with knee joint pain and disability.
- Brand
Conformis- Category
Medical device
What to do — step by step
Check Product Labels
Look for model number TCR-121-1111-010102 and serial numbers 0432428 or 0432212 on the product packaging or documentation.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of serious injury from this product?
The recall is due to potential incorrect patient matches during surgery, which could lead to complications. However, the hazard is not described as causing death or serious injury in normal use, so the risk level is low.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
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-1108-2019 (December 3, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1108-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.