Z-1487-2018 Class II Terminated
FDA device recall Z-1487-2018 was initiated by Integra LifeSciences Corp. on August 18, 2017 and is designated Class II. 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. The recall status is terminated (terminated July 19, 2018). Affected quantity: 250.
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- August 18, 2017
- Termination Date
- July 19, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 250
Product Description
TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
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.
Distribution Pattern
US nationwide distribution.
Code Information
Lot 1216033