Recall Z-1487-2018— Integra LifeSciences Corp.
Class II · Terminated
Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2017-08-18, terminated 2018-07-19. FDA's recall record names no specific 510(k) clearance for this event. Product: TCC-EZ, Total Contact Cast System, Model No. TCC2-4051. 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..
- Recalling firm
- Integra LifeSciences Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-08-18
- Terminated
- 2018-07-19
- Firm location
- Plainsboro, NJ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.