FDA Medical Device Recalls (openFDA)
Nextremity Solutions: Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT
- Recall number
- Z-0740-2022
- Recalling firm
- Nextremity Solutions
- Product
- Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT
- Status
- Terminated
- Initiated
- 2022-01-13
- Posted
- not on file
- Terminated
- 2024-05-24
- 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 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
- 24 units
- Distribution
- US Nationwide distribution in the states of AZ, IL, GA, LA, MD, NY, PA, TX, WA.
- Lot, serial or model codes
- Lot Numbers: 1574701, 158961 UDI: 00817701026372
- 510(k) numbers
- ["K200840","K213530"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 3009540749
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28