Z-0739-2022Class II

Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to...

Name: Z-0739-2022 Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to...
Creator: Nextremity Solutions
Published: 2022-01-13
License: https://open.fda.gov/license/

Medartis AG / initiated 2022-01-13 / Terminated / root cause: design

FDA source

Nextremity Solutions began a recall of Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU... on 2022-01-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0739-2022
Classification: Class II
Status: Terminated
Initiated: 2022-01-13
Posted: 2022-03-09
Terminated: 2024-05-24
Recalling firm: Medartis AG
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
Product code: HWC Screw, Fixation, Bone
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
Root cause tag: design
FDA 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 [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].
Quantity in commerce: 23 units
Distribution: US Nationwide distribution in the states of AZ, IL, GA, LA, MD, NY, PA, TX, WA.
Product codes and lots: Lot Number: 1578401 UDI: 00817701026389

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0739-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0739-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-16	2022-03-09
Z-0740-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-16	2022-03-09

Product code HWC

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)