Affixus® 8145-50-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887868567063), received between Apr 28, 2025 and Apr 28, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

250 other recalls cover devices cleared under the same FDA submission (K100238, K111444); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS A LEFT FEMUR FRACTURE REPAIR. APPROXIMATELY 90 DAYS POST IMPLANTATION, THE PATIENT WAS EXPERIENCING PAIN AND HAD X-RAYS WHICH INDICATED THE DISTAL FEMORAL CORTICAL SCREW HAD FRACTURED. PATIENT ALSO REPORTED AMBULATION DIFFICULTIES AND ALTERED GAIT AS A RESULT OF THE MALFUNCTION. THE SURGEON INDICATED IMPLANT FRACTURE DID NOT REQUIRE EXPLANATION OR REVISION CHANGE AT THIS TIME. NO EXTERNAL TRAUMA OR FALLS OCCURRED.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Pain

  MAUDE report 21918757 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100238, K111444. One submission often covers many models, so check the product and lot details in each record.

• Z-0454-2019 · Oct 2, 2018 · Terminated
  Affixus Hip Fracture Nail 130 Deg 12x165mm, Item Number 816812165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullar
• Z-0452-2019 · Oct 2, 2018 · Terminated
  Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullar
• Z-0450-2019 · Oct 2, 2018 · Terminated
  Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedu
• Z-0447-2019 · Oct 2, 2018 · Terminated
  Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullar
• Z-0453-2019 · Oct 2, 2018 · Terminated
  Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullar
• Z-0451-2019 · Oct 2, 2018 · Terminated
  Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullar
• Z-0448-2019 · Oct 2, 2018 · Terminated
  Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramed
• Z-0449-2019 · Oct 2, 2018 · Terminated
  Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramed
• Z-0154-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number 814413260 Product Usage: Intended for the fixation of fractures
• Z-0162-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number 814511400 Product Usage: Intended for the fixation of fractures
• Z-0159-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Right 130 11 mm x 320 mm, Item Number 814511320 Product Usage: Intended for the fixation of fractures
• Z-0164-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Left 130 9 mm x 360 mm, Item Number 814609360 Product Usage: Intended for the fixation of fractures
• Z-0149-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Left 125 9 mm x 460 mm, Item Number 814409460 Product Usage: Intended for the fixation of fractures
• Z-0134-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number 814311380 Product Usage: Intended for the fixation of fractures
• Z-0148-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number 814409440 Product Usage: Intended for the fixation of fractures

…and 235 more.