FDA Recall
Terminated
TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
Recall: Z-1487-2018
·
Initiated August 18, 2017
Recall
- Recall Number
- Z-1487-2018
- Event Number
- 79636
- Firm
- Integra LifeSciences Corp.
- FEI Number
- 3003418325
- Product Code
- ITG
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- August 18, 2017
- Terminated
- July 19, 2018
- Address
- 311 Enterprise Dr, Plainsboro, NJ, 08536-3344
Description
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.
Action
On 8/18/17, the recalling firm's sales reps notified affected consignees of the recall and distributed customer letters. Customers were asked to examine their inventory for product from the affected lot, warned not to use the product, complete the included "Acknowledgement and Return Form", and return the form by email or fax. Customers were provided with a Customer Service number: 1-800-654-2873.
Distribution
US nationwide distribution.
Quantity
250