Recall Z-1487-2018 ยท ITG Bandage, Cast
Integra LifeSciences Corp.
TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
| Date | Aug 18, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| 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. |
| Quantity | 250 |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.