Lower riskMedical device recall · FDA · Published February 12, 2020
Nextremity Nextra Hammertoe Correction System recall: Oversized driver may cause
Nextremity recalls Nextra Hammertoe Correction System-4.5MM Middle, : Oversized proximal driver may cause difficulty connecting with implant. Affected units have lot number 168117318B and UDI 00817701020011.
Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the proximal Nextra implant
Take action
Contact the company
📍Recalling firmNextremity Solutions6210 N Buffalo St · Warsaw, IN 46580
“Nextremity Nextra Hammertoe Correction System recall: Oversized driver may cause.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65852-nextremity-nextra-hammertoe-correction-system-recall-oversized-driver-may-cause. Based on FDA recall #Z-1458-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1458-2020%22&limit=1).
Nextremity Solutions voluntarily recalled the Nextra Hammertoe Correction System on Feb. 12, 2020, according to the FDA. The agency said the driver's proximal end may be oversized, potentially making it difficult to connect with and remove from the implant.
Distribution: Spain, United Kingdom, Germany, and Switzerland
The hazard
The proximal end of the driver in the affected product may be oversized in varying degrees. This defect potentially makes it difficult to connect with and remove from the proximal Nextra implant.
Context
GovInfoNow's records show Nextremity Solutions has 6 other recalls on record since Oct. 9, 2019. Other recent recalls of similar products include Nextremity Nextra Hammertoe Kit Recall (Feb. 10, 2022), Nextrem: Cannulated Hammertoe Kit May Cause Surgical Delay or Revision (Jan. 13, 2022), and Nextremity InCore Lapidus Kit 28mm Left: Drill Bushing Size Risk (March 26, 2021). Straumann Dental Implant Abutments Recall occurred on March 27, 2026.
How to tell if you have this one
Check for the lot number 168117318B or unique device identifier (UDI) 00817701020011 on the implant packaging. The product is the Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile with reference number NX-4532K.
Brand
Nextremity
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the lot number 168117318B or UDI 00817701020011 on the implant packaging.
How this recall unfolded
Recall timeline
FDA terminated this recall 10 months 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-1458-2020 (February 12, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1458-2020 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.