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
Recall
- Recall Number
- Z-0739-2022
- Event Number
- 89588
- Firm
- Nextremity Solutions
- FEI Number
- 3009540749
- Product Code
- HWC
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- January 13, 2022
- Terminated
- May 24, 2024
- Address
- 1195 Polk Dr, Warsaw, IN, 46582-8602
Description
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
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
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 [email protected] within three (3) days. This form must be returned even if you do not have affected products available to return in your territory. b. For each return, send a copy of Attachment 1 to [email protected]. c. Include a hardcopy of Attachment 1 in the package/box with your return shipment. d. Mark "RECALL" on the outside of the package/box. e. Ship to the address provided in Attachment 1- Medical Device Recall Return Response. 4. Retain a copy of your shipping documentation and Attachment 1- Medical Device Recall Return Response for your records in the event of a compliance audit of your facility. 5. If you have further questions or concerns after reviewing this notice, please call Nextremity Solutions at 574-376-2404 between 8:00 am and 5:00pm EST, Monday through Friday. Request to speak to a representative from quality and regulatory. Calls received outside of operating hours will receive a voicemail prompt. Alternatively, your questions may be emailed to [email protected].
US Nationwide distribution in the states of AZ, IL, GA, LA, MD, NY, PA, TX, WA.
23 units