Conform: iTotal CR Knee Replacement System Recall - Label Mixup Risk
Conformis recalls iTotal CR knee implants with incorrect box contents. Check serial number 0469247 (exp 2021-01-31) for affected units. No immediate action needed.
Lower-risk recall
Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
Contact the company
What happened, in plain English
Conformis is recalling a specific knee replacement implant kit due to a mix-up in the box contents. This means some customers might receive the wrong implant components, which could lead to improper surgical procedures. Read more at govinfonow.com/recall/64688-conform-itotal-cr-knee-replacement-system-recall-label-mixup-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/64688-conform-itotal-cr-knee-replacement-system-recall-label-mixup-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2849-2020
Cite this page
“Conform: iTotal CR Knee Replacement System Recall - Label Mixup Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64688-conform-itotal-cr-knee-replacement-system-recall-label-mixup-risk. Based on FDA recall #Z-2849-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2849-2020%22&limit=1).
Why it’s dangerous
The recall is caused by a mix-up in the box contents. The outer labels for kit 0469247 correctly state the product, but the boxes actually contain the implants and jigs for a different kit (0468920). This could lead to using the wrong components during surgery.
Who’s affected
Patients who received the Conformis iTotal CR knee implant kit with serial number 0469247 (expiring January 31, 2021) are affected. Surgeons using this specific kit during procedures are at higher risk.
How to tell if you have this one
Check for the serial number 0469247 on the implant kit box. The expiration date is January 31, 2021. This specific kit was sold with the product name 'ITOTAL CR IPOLY XE IMPLANT KIT LEFT'.
- Brand
Conformis- Category
Medical device
What to do — step by step
Check Kit Serial Number
Look for the serial number 0469247 on the implant kit box.
Where it went and when
Where it was distributed
Distributed in Nevada.
FDA distribution: “NV” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Nevada.
Recall timeline
FDA terminated this recall 11 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.
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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-2849-2020 (July 20, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2849-2020 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.