Recall Z-2296-2016 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Integra LifeSciences Corp.
Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of external fixation.
| Date | Jul 1, 2016 |
| Status | Terminated |
| Reason | The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold. |
| Root cause | Device Design |
| Action | All affected consignees were notified via an "Urgent: Voluntary Medical Device Recall" letter sent on 7/1/16. The letter identified the affected product as well as the reason for the recall. Customers were asked to check their traceability records for shipments of the affected product. If the affected parts are found, customers are to stop use and distribution. A copy of the letter should be provided to any customers that the product may have been distributed to. The attached "Acknowledgement and Return Form" should be completed and returned regardless if customers have affected product o |
| Quantity | 27 units |
| Distribution | Distributed in the US to the states of FL, VA, OK, CO, DC, and IN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140463 | INTEGRA EXTERNAL FIXATION SYSTEM Ascension Orthopedic, Oct 10, 2014 |