Nextra Hammertoe Correction System NX-4532KRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00817701020011), received between Mar 5, 2019 and Jan 3, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (1 report).

2 FDA recall records name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Feb 10, 2022Terminated

   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

   Z-0910-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Feb 12, 2020Terminated

   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

   Z-1458-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A SURGERY USING THE NEXTRA HAMMERTOE CORRECTION SYSTEM, THE IMPLANT COMPONENTS COULD NOT BE LOCKED TOGETHER. A SECOND SET UP IMPLANTS WAS OPENED TO COMPLETE THE SURGERY. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9545820 ↗
• MalfunctionJun 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DRIVER DID NOT FIT INTO THE PROXIMAL IMPLANT. A SURGICAL DELAY OF GREATER THAN 30 MINUTES WAS REPORTED. THE SURGERY WAS COMPLETED WITH A KWIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8745167 ↗
• MalfunctionApr 3, 2019Nonstandard Device; Product Quality Problem; Manufacturing, Packaging or Shipping Problem; Nonstandard Device; Product Quality Problem; Manufacturing, Packaging or Shipping Problem

  FAILURE OF THREE PROXIMAL 3.2MM NEXTRA IMPLANTS TO ENGAGE WITH A 4.5MM MIDDLE NEXTRA IMPLANT IN THE SAME SURGERY. THE PROCEDURE WAS COMPLETED WITH A K-WIRE. A SURGICAL DELAY OF >30 MINUTES WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8479704 ↗
• MalfunctionMar 5, 2019Mechanical Problem; Failure to Align; Mechanics Altered; Mechanical Problem; Failure to Align; Mechanics Altered

  THE SURGEON REPORTED FAILURE OF THE FEMALE(PROXIMAL) 4.5MM NEXTRA COMPONENT TO ENGAGE WITH THE MALE (MIDDLE) COMPONENT ON TWO SEPARATE NX-4532K DEVICES WITHIN THE SAME SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY AFTER THE REPORTED DEVICE FAILURES. A SURGICAL DELAY OF GREATER THAN 30 MINUTES WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8392392 ↗