Integra TCC-EZ Cast System Recall: Risk of Overheating
Integra LifeSciences recalls TCC-EZ Total Contact Cast System Model TCC2-4051 due to potential overheating from increased exothermic reactions. Affected units sold in specific lots may exceed safety specifications.
Lower-risk recall
A quarantined lot of the devices was released for sale. Devices from this lot may experience increased exothermic reaction causing higher levels of heat output which exceed the product specifications.
Contact the company
What happened, in plain English
Integra LifeSc: TCC-EZ Total Contact Cast System model TCC2-4051 is recalled because a specific lot may overheat due to increased heat output. This could cause injury if the cast becomes too hot to handle. Read more at govinfonow.com/recall/73134-integra-tcc-ez-cast-system-recall-risk-of-overheating.
Source Summary by GovInfoNow · govinfonow.com/recall/73134-integra-tcc-ez-cast-system-recall-risk-of-overheating · Updated September 18, 2026 · FDA enforcement record: FDA #Z-1487-2018
Cite this page
“Integra TCC-EZ Cast System Recall: Risk of Overheating.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73134-integra-tcc-ez-cast-system-recall-risk-of-overheating. Based on FDA recall #Z-1487-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1487-2018%22&limit=1).
Why it’s dangerous
The recalled lot of devices may produce more heat than intended due to an increased exothermic reaction. This could lead to the cast becoming too hot for safe handling, potentially causing burns or skin damage.
Who’s affected
Patients using the TCC-EZ Total Contact Cast System model TCC2-4051 from lot 1216033 are affected. Those with casts that feel unusually hot or cause skin irritation may be at higher risk.
How to tell if you have this one
Check for the model number TCC2-4051 on the cast system. The affected lot number is 1216033. This product was sold in specific batches.
- Brand
Integra LifeSciences- Category
Medical device
What to do — step by step
Check for Heat Symptoms
If the cast feels unusually hot or causes skin irritation, stop using it immediately.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
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.
Questions people ask
Is this product dangerous?
The recall indicates a potential risk of overheating, but the hazard is not severe enough to require immediate stop-use. The risk is low and depends on specific conditions.
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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-1487-2018 (August 18, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1487-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 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.