ConforMIS Total Knee Replacement Kit Recalled Due to Labeling Error
ConforMIS recalls total knee replacement kits with model TPS-111-1111 that have mislabeled implant kits. Affected units include specific serial numbers and expiration dates. Consumers should contact the manufacturer for details.
Recall notice
Implant kit mislabeled
Contact the company
What happened, in plain English
ConforMIS is recalling total knee replacement kits with model number TPS-111-1111 that have mislabeled implant kits. This issue could lead to incorrect surgical procedures if the wrong kit is used during surgery. Read more at govinfonow.com/recall/73377-conformis-total-knee-replacement-kit-recalled-due-to-labeling-error.
Source Summary by GovInfoNow · govinfonow.com/recall/73377-conformis-total-knee-replacement-kit-recalled-due-to-labeling-error · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0600-2018
Cite this page
“ConforMIS Total Knee Replacement Kit Recalled Due to Labeling Error.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73377-conformis-total-knee-replacement-kit-recalled-due-to-labeling-error. Based on FDA recall #Z-0600-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0600-2018%22&limit=1).
Why it’s dangerous
The implant kit is mislabeled, which could result in the wrong surgical implant being used during knee replacement procedures. This might cause incorrect joint alignment or improper healing after surgery.
Who’s affected
Patients who have received a total knee replacement kit with model TPS-111-1111 and serial numbers 0398482 or 0399917 are affected. Surgeons and medical facilities using these kits are at risk of using the wrong implant.
How to tell if you have this one
Check for the model number TPS-111-1111 on the implant kit packaging. Look for serial numbers 0398482 or 0399917 on the kit's documentation. The expiration date for these kits is December 31, 2017.
- Brand
ConforMIS- Category
Medical device
What to do — step by step
Check Kit Documentation
Review the implant kit's documentation for the model number TPS-111-1111 and serial numbers 0398482 or 0399917.
Where it went and when
Where it was distributed
Distributed in California and Texas.
FDA distribution: “US Distribution to the states of :CA and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Texas.
Recall timeline
FDA terminated this recall 18 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-0600-2018 (July 24, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0600-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 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.