Recall Z-1539-2017 ยท HSB Rod, Fixation, Intramedullary And Accessories
Integra LifeSciences Corp.
Panta Nail, Rx only, Sterile,
| Date | Mar 3, 2017 |
| Status | Terminated |
| Reason | Voluntary recall/Removal of Panta and Panta XI Nails because there may be the potential that the internal and external package seal does not provide the level of sterility intended. |
| Root cause | Packaging change control |
| Action | Integra sent "Urgent Medical Device Recall Letters and Return Response Forms" dated March 3, 2017 to their distributors and customers. All customers were asked to examine their inventory to determine if they had the recalled lots and if they did they are instructed to stop using them immediately. Distributors are asked if the recalled product was further distributed, those customers should be notified and instructed to follow the recalling procedures. The return response form should be completed, even if they do not have any recalled lots, annotating the amount of product and list a record of |
| Quantity | 4,449 units |
| Distribution | US Nationwide and Internationally |
| FDA record | Open on fda.gov |