UnratedMedical device recall · FDA · Published January 13, 2022
Nextrem: Cannulated Hammertoe Kit May Cause Surgical Delay or Revision
Nextremity Solutions recalls its Nextra CH Cannulated Hammertoe Mini Instrument Kit for potential surgical complications. The device may deform the implant locking mechanism during insertion, leading to delays or revision surgery.
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
Take action
Contact the company
📍Recalling firmNextremity Solutions1195 Polk Dr · Warsaw, IN 46582-8602
“Nextrem: Cannulated Hammertoe Kit May Cause Surgical Delay or Revision.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61270-nextrem-cannulated-hammertoe-kit-may-cause-surgical-delay-or-revision. Based on FDA recall #Z-0739-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0739-2022%22&limit=1).
The FDA announced on Jan. 13, 2022, that Nextremity Solutions is recalling the Nextra CH Cannulated Hammertoe Mini Instrument Kit due to a hazard that may cause surgical delays and require implant removal. The agency classified the recall as Class II.
How to tell if you have it
Brand: Nextremity Solutions
Product: Nextra CH Cannulated Hammertoe Mini Instrument Kit
SKU: CH-MINI-KT
Lot Number: 1578401
UDI: 00817701026389
The hazard
According to the FDA, during insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism. This can result in inadequate mating force between the middle and proximal phalanx implants, leading to surgical delay, in-situ removal of the implant, use of an alternative surgical approach, disassembly of the implants post-operatively, and revision.
Context
GovInfoNow's records show Nextremity Solutions has 6 other recalls on record since Oct. 9, 2019. Other recent recalls of similar products include Medartis APTUS Screws (April 24, 2026) and Merit Medical Custom Inflation Kit (Dec. 4, 2025).
How to tell if you have this one
Check for the SKU: CH-MINI-KT and Lot Number: 1578401 on the kit. The UDI is 00817701026389. This kit is used for small bone reconstruction in the toes.
Brand
Nextremity Solutions
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Nationwide distribution in the states of AZ, IL, GA, LA, MD, NY, PA, TX, WA.
Recall number
Product, codes & lots
Quantity
Z-0739-2022
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; Lot Number: 1578401 UDI: 00817701026389
23 units
Z-0740-2022
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; Lot Numbers: 1574701, 158961 UDI: 00817701026372
24 units
Based on the official FDA remedy
What to do — step by step
Contact Manufacturer
Reach out to Nextremity Solutions directly for guidance on the recall.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 9 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AZ, IL, GA, LA, MD, NY, PA, TX, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Georgia, Illinois, Louisiana, Maryland, New York, Pennsylvania, Texas, Washington.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0739-2022 (January 13, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0739-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.