CLASS II Device recall · Reported 2 May 2018 · FDA Enforcement Report

Tcc-ez, Total Contact Cast System recalled by Integra LifeSciences

Integra LifeSciences is recalling Tcc-ez, Total Contact Cast System, distributed nationwide in the US. The recall was initiated on 18 Aug 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 1216033

Quantity recalled250

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1487-2018
FDA event ID: 79636
Recalling firm: Integra LifeSciences, Plainsboro, NJ
Classification: Class II
Status: Terminated
Recall initiated: 18 Aug 2017
FDA classified: 24 Apr 2018
Reported: 2 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

18 Aug 2017	Recall initiated by company
24 Apr 2018	Classified by FDA	+249 days
2 May 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for 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.

Product as listed by the FDA

TCC-EZ, Total Contact Cast System, Model No. TCC2-4051

Where it was distributed

US nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot 1216033

Where was it sold?

US nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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