LINK Instrument 184-360/00Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04026575185948), received between Jul 14, 2023 and Aug 29, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K171273); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2023Mechanical Jam; Mechanical Jam

  LOCKING OF THE PRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17641887 ↗
• MalfunctionAug 29, 2023Mechanical Jam; Mechanical Jam

  HEAVY ROTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17641718 ↗
• MalfunctionAug 29, 2023Mechanical Jam; Mechanical Jam

  THREAD CUT TOGETHER AND STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17641713 ↗
• MalfunctionAug 29, 2023Fracture; Fracture

  GUIDE RAIL BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17641708 ↗
• MalfunctionJul 14, 2023Fracture; Material Fragmentation; Fracture; Material Fragmentation

  PIN GUIDE OF PRESS BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17324043 ↗
• MalfunctionJul 14, 2023Material Fragmentation; Mechanical Jam; Material Fragmentation; Mechanical Jam

  METAL SPLINTER HAS LOOSENED FROM THE THREADED ROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17324042 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171273. One submission often covers many models, so check the product and lot details in each record.

• Z-0729-2019 · Dec 4, 2018 · Terminated
  BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or
• Z-0728-2019 · Dec 4, 2018 · Terminated
  BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or