FDAFDA · Food and drugs·Recall number Z-1487-2018
TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
Published May 2, 2018 · Recall initiated: August 18, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Integra LifeSciences Corp.
- Distributor
- US nationwide distribution.
- Lot
- Lot 1216033
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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