Recall Z-0739-2022 ยท HWC Screw, Fixation, Bone
Nextremity Solutions
Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT
| Date | Jan 13, 2022 |
| Status | Terminated |
| Reason | During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ removal of the implant, use of alternative surgical approach, disassembly of the implants post-operatively, and revision |
| Root cause | Device Design |
| Action | Nextremity Solution issued URGENT Medical Device Recall dated 1/13/22. Letter states reason for recall, health risk and action to take: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product (see Table 1 above) in your trunk stock inventory. 3. Immediately return all affected product from your trunk stock inventory. a. Complete Attachment 1- Medical Device Recall Return Response and send to QA@nextremity.com within three (3) days. This form must be returned even if you do not have affected products ava |
| Quantity | 23 units |
| Distribution | US Nationwide distribution in the states of AZ, IL, GA, LA, MD, NY, PA, TX, WA. |
| FDA record | Open on fda.gov |