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Recall Observatory FDA recall evidence

Device product

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

Z-1487-2018

August 18, 2017

Class II

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 79636
Status
Terminated
Classification
Class II
Quantity
250
Official record key
device-enforcement:Z-1487-2018

Official wording

Reason: 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.

Code information: Lot 1216033

Distribution pattern: US nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.