Lower riskMedical device recall · FDA · Published February 10, 2022
Nextremity Nextra Hammertoe Correction System 3.5/3.2 Proximal Saw Cut: Surgical
Nextremity recalls specific orthopedic surgical instruments due to oversized driver causing surgery delays. Affected units have SKU NX-3532K-SC and lot number 1681250:17B.
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
Take action
Contact the company
📍Recalling firmNextremity Solutions1195 Polk Dr · Warsaw, IN 46582-8602
“Nextremity Nextra Hammertoe Correction System 3.5/3.2 Proximal Saw Cut: Surgical.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61159-nextremity-nextra-hammertoe-correction-system-3-5-3-2-proximal. Based on FDA recall #Z-0913-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0913-2022%22&limit=1).
Nextremity Solutions voluntarily recalled the Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut (SKU: NX-3532K-SC) on Feb. 10, 2022, according to the FDA. The orthopedic surgical instrument poses a hazard because an oversized driver proximal end may make it difficult to fully connect with and remove from the implant.
How to tell if you have it
Brand: Nextremity Solutions
Product: Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut
SKU: NX-3532K-SC
Lot Number: 168125017B
UDI: 00817701020059
Units affected: 89
The hazard
The proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant. This defect causes delay in surgery.
Context
GovInfoNow's records show Nextremity Solutions has 6 other recalls on record since Oct. 9, 2019. Other recent recalls of similar products include a Jan. 13, 2022 recall for the Nextrem Cannulated Hammertoe Kit and a March 26, 2021 recall for the Nextremity InCore Lapidus Kit 28mm Right. A Feb. 12, 2020 recall of the Nextra Hammertoe Correction System also cited an oversized driver causing connection difficulties.
How to tell if you have this one
Check for SKU number NX-3532K-SC on the instrument. Affected units were manufactured with lot number 168125017B and have UDI 00817701020059.
Brand
Nextremity Solutions
Category
Medical device
FDA recall event · 5 products
All 5 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
Distribution US Nationwide, Japan, and the Netherlands
Recall number
Product, codes & lots
Quantity
Z-0910-2022
Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument; Lot Number: 168117318B, 168125017C UDI: 00817701020011
4 units
Z-0911-2022
Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument; Lot Number: 168117318C, 168125017D UDI: 00817701020004
459 units
Z-0912-2022
Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument; Lot Number: 168125017A UDI: 00817701020042
285 units
Z-0913-2022
Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument; Lot Number: 168125017B UDI: 00817701020059
89 units
Z-0914-2022
Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument; Lot Number: 168A27917C UDI: 00817701020837
239 units
Based on the official FDA remedy
What to do — step by step
Check Instrument Details
Verify the SKU number is NX-3532K-SC and lot number 168125017B.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Distribution US Nationwide, Japan, and the Netherlands” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.7 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-0913-2022 (February 10, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0913-2022 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.