Nextra Hammertoe Correction SystemRecalls & reported problems across all models
Medartis Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 6
We found 5 models of Nextra Hammertoe Correction System by Medartis Inc. in the FDA's device registry (GUDID). Together they are named in 9 adverse event reports in the FDA's MAUDE database, received between Mar 5, 2019 and Feb 10, 2021 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (2 reports).
6 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Nextra Hammertoe Correction System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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-0914-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- 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-0913-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- 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-0912-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- 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-0911-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- 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 ↗
- 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 Nextra Hammertoe Correction System problems
Device problems
- No Apparent Adverse Event5
- Mechanical Problem2
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Failure to Align1
- Manufacturing, Packaging or Shipping Problem1
- Mechanics Altered1
- Nonstandard Device1
Patient problems
- No Known Impact Or Consequence To Patient9
Nextra Hammertoe Correction System models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Nextra Hammertoe Correction System NX-4532KScrew, Fixation, Bone2 recalls4 reports
- Nextra Hammertoe Correction System NX-3532K-SCScrew, Fixation, Bone1 recall5 reports
- Nextra Hammertoe Correction System NX-4532K-SCScrew, Fixation, Bone1 recall0 reports
- Nextra Hammertoe Correction System NX-3532KScrew, Fixation, Bone1 recall0 reports
- Nextra Hammertoe Correction System NX-DROrthopedic Manual Surgical Instrument1 recall0 reports
Recent Nextra Hammertoe Correction System adverse event reports
The 9 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 10, 2021No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT DURING A SURGERY WITH THE NEXTRA HAMMERTOE CORRECTION SYSTEM, THE PROXIMAL AND MIDDLE IMPLANTS DID NOT SIT FLUSH ON THE NEXTRA DRIVER. THIS CONDITION DID NOT AFFECT THE SURGERY. THE SURGERY WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 11309456 ↗MalfunctionMar 4, 2020No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2020 USING THE NEXTRA HAMMERTOE CORRECTION SYSTEM, THE PROXIMAL IMPLANT COMPONENT COULD NOT BE DISENGAGED FROM THE DRIVER. A SECOND KIT WAS OPENED TO COMPLETE THE SURGERY. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9786594 ↗MalfunctionJan 10, 2020No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT DURING A SURGERY WITH THE NEXTRA HAMMERTOE CORRECTION SYSTEM THE PROXIMAL IMPLANT WOULD NOT SIT FLAT ON THE SCREWDRIVER. A SECOND SCREWDRIVER WAS OPENED TO COMPLETE THE SURGERY. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9578284 ↗MalfunctionJan 10, 2020No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT DURING AN OPERATION PERFORMED WITH THE NEXTRA HAMMERTOE CORRECTION SYSTEM, THE SURGEON HAD DIFFICULTY MATING THE DISTAL END OF THE NEXTRA DRIVER WITH THE DISTAL IMPLANT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH AN ALTERNATE DRIVER. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9576550 ↗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 14, 2019Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement; Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement
THE PATIENT UNDERWENT HAMMERTOE SURGERY ON (B)(6) 2019. AFTER SURGERY, X-RAYS SHOWED THE IMPLANT HAD DISLOCATED. THE PATIENT CAME BACK INTO THE DOCTOR'S OFFICE THE FOLLOWING DAY FOR THE SURGEON TO ATTEMPT TO FIX THE DISLOCATION. THIS WAS NOT SUCCESSFUL. THE PATIENT WAS SCHEDULED FOR SURGERY ON (B)(6) 2019, AT WHICH POINT THE SURGEON REMOVED THE DISLOCATED 3.5MM MIDDLE IMPLANT. THE SURGEON IMPLANTED A 4.5 MIDDLE IMPLANT TO REPLACE THE IMPLANT. THIS WAS SUCCESSFUL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8422053 ↗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 ↗
Other Medartis Inc. products
All Medartis Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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