Class 2 Device Recall Nextra

• Date Initiated by Firm: January 13, 2022
• Create Date: March 09, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0739-2022
• Recall Event ID: 89588
• 510(K)Number: K200840 K213530
• Product Classification: Screw, fixation, bone - Product Code HWC
• Product: 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
• Code Information: Lot Number: 1578401 UDI: 00817701026389
• Recalling Firm/ Manufacturer: Nextremity Solutions; 1195 Polk Dr; Warsaw IN 46582-8602
• For Additional Information Contact: SAME; 574-3762062
• Manufacturer Reason for Recall: 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
• FDA Determined 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 available to return in your territory. b. For each return, send a copy of Attachment 1 to QA@nextremity.com. 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 QA@nextremity.com.
• Quantity in Commerce: 23 units
• Distribution: US Nationwide distribution in the states of AZ, IL, GA, LA, MD, NY, PA, TX, WA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HWC and Original Applicant = Nextremity Solutions, Inc.