Recall Z-2387-2016 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Integra LifeSciences Corp.
Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229
| Date | Jul 20, 2016 |
| Status | Terminated |
| Reason | Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site. |
| Root cause | Device Design |
| Action | Integra sent an Urgent - Voluntary Medical Device Recall letter dated July 20, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Integra is asking you to take the following actions: 1. Please check your Integra External Fixation System inventory to determine if you have the 17.5mm or 23mm Universal Wire Fixation Bolts and/or the large or small Slotted Posts. 2. If you do have 17.5mm or 23mm Universal Wire Fixation Bolts and/or large or small Slotted Posts, stop using them immediately. 3. Complete the atta |
| Quantity | 111 units |
| Distribution | US Distribution to the states of : FL, VA, OK, CO, DC and IN. |
| FDA record | Open on fda.gov |