AFFIXUSHIP FRACTURE NAIL - LEFTRecalls & reported problems across all models

We found 27 models of AFFIXUSHIP FRACTURE NAIL - LEFT by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, received between Jul 6, 2022 and Oct 30, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (6 reports).

24 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

AFFIXUSHIP FRACTURE NAIL - LEFT 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.

1. Aug 7, 2017Terminated

   During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

   Z-0447-2018 · Root cause: Process change control · Recall details · FDA record ↗

2. Aug 7, 2017Terminated

   During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

   Z-0446-2018 · Root cause: Process change control · Recall details · FDA record ↗

3. Aug 7, 2017Terminated

   During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

   Z-0445-2018 · Root cause: Process change control · Recall details · FDA record ↗

4. Aug 7, 2017Terminated

   During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

   Z-0444-2018 · Root cause: Process change control · Recall details · FDA record ↗

5. Aug 7, 2017Terminated

   During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

   Z-0443-2018 · Root cause: Process change control · Recall details · FDA record ↗

6. Aug 7, 2017Terminated

   During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

   Z-0442-2018 · Root cause: Process change control · Recall details · FDA record ↗

7. Aug 7, 2017Terminated

   During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

   Z-0441-2018 · Root cause: Process change control · Recall details · FDA record ↗

8. Aug 7, 2017Terminated

   During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

   Z-0440-2018 · Root cause: Process change control · Recall details · FDA record ↗

9. Aug 7, 2017Terminated

   During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

   Z-0439-2018 · Root cause: Process change control · Recall details · FDA record ↗

10. Aug 7, 2017Terminated

    During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

    Z-0438-2018 · Root cause: Process change control · Recall details · FDA record ↗

11. Aug 7, 2017Terminated

    During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

    Z-0437-2018 · Root cause: Process change control · Recall details · FDA record ↗

12. Aug 7, 2017Terminated

    During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

    Z-0436-2018 · Root cause: Process change control · Recall details · FDA record ↗

13. Aug 7, 2017Terminated

    During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

    Z-0435-2018 · Root cause: Process change control · Recall details · FDA record ↗

14. Aug 7, 2017Terminated

    During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

    Z-0434-2018 · Root cause: Process change control · Recall details · FDA record ↗

15. Aug 7, 2017Terminated

    During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

    Z-0433-2018 · Root cause: Process change control · Recall details · FDA record ↗

16. Aug 7, 2017Terminated

    During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

    Z-0432-2018 · Root cause: Process change control · Recall details · FDA record ↗

17. Aug 7, 2017Terminated

    During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

    Z-0431-2018 · Root cause: Process change control · Recall details · FDA record ↗

18. Aug 7, 2017Terminated

    During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

    Z-0430-2018 · Root cause: Process change control · Recall details · FDA record ↗

19. Aug 7, 2017Terminated

    During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

    Z-0429-2018 · Root cause: Process change control · Recall details · FDA record ↗

20. Aug 7, 2017Terminated

    During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

    Z-0428-2018 · Root cause: Process change control · Recall details · FDA record ↗

21. Aug 7, 2017Terminated

    During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

    Z-0427-2018 · Root cause: Process change control · Recall details · FDA record ↗

22. Aug 7, 2017Terminated

    During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

    Z-0426-2018 · Root cause: Process change control · Recall details · FDA record ↗

23. Aug 7, 2017Terminated

    During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

    Z-0425-2018 · Root cause: Process change control · Recall details · FDA record ↗

24. Aug 7, 2017Terminated

    During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

    Z-0424-2018 · Root cause: Process change control · Recall details · FDA record ↗

Most reported AFFIXUSHIP FRACTURE NAIL - LEFT problems

AFFIXUSHIP FRACTURE NAIL - LEFT models

27 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AFFIXUS®HIP FRACTURE NAIL - LEFT 8144-09-440

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall1 report
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8144-11-440

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall1 report
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8146-11-340

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall1 report
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8146-11-400

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall1 report
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8144-09-260

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8144-09-340

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8144-09-380

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8144-11-320

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8144-11-360

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8146-09-280

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8146-09-300

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8146-09-320

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8146-09-340

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8146-09-400

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8146-09-420

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8146-09-440

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8146-11-260

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8146-11-280

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8146-11-300

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8146-11-380

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8146-11-420

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8146-11-440

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8146-11-460

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8146-13-460

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8146-09-380

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 report
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8146-13-360

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 report
• AFFIXUS®HIP FRACTURE NAIL - LEFT 8146-13-380

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 report

Recent AFFIXUSHIP FRACTURE NAIL - LEFT adverse event reports

The 7 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT FEMUR FRACTURE SURGERY. SUBSEQUENTLY, THE PATIENT WAS REVISED ON APPROXIMATELY 1 MONTH POST-IMPLANTATION DUE TO THE AFFIXUS NAIL BREAKING AT THE LAG SCREW HOLE AND REQUIRED A CONVERSION TO ARCOS HEMI. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 23422693 ↗
• InjuryJan 14, 2025Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture; Pain; Swelling/ Edema

  MAUDE report 21150397 ↗
• InjuryJun 17, 2024Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 19547283 ↗
• InjuryDec 7, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18283791 ↗
• InjuryOct 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP SURGERY ON AND UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY TWO (2) MONTHS AGO DUE TO THE IMPLANT FRACTURING. THERE WAS NO REPORT OF A FOREIGN BODY BEING RETAINED BY THE PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 17861580 ↗
• InjuryAug 10, 2022Fracture; Fracture

  ON AN UNKNOWN DATE A PATIENT HAD AN INITIAL SURGERY. ON ANOTHER UNKNOWN DATE THE PATIENT CAME IN FOR A REVISION DUE TO AN IMPLANTED NAIL FRACTURE.

  Patient problems: Failure of Implant

  MAUDE report 15199681 ↗
• MalfunctionJul 6, 2022Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE NAIL DID NOT PROPERLY ASSEMBLE TO THE JIG. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14936190 ↗

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