BiMobile 184-101/46Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026575174362), received between May 22, 2023 and May 24, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Expiration Date Error” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 24, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  LINKBIO WAS NOTIFIED BY REPRESENTATIVE R.R. THAT THE BIMOBILE SHELL IMPLANTED ON (B)(6) 2023 HAD AN EXPIRATION DATE OF FEB. 2023. THE SHELL WAS THEN REMOVED AND REPLACED WITH A CLUSTER-HOLE IMPLANT INSTEAD, WITH A CHANGED OUT LINER IN ORDER TO CONVERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16997157 ↗
• InjuryMay 22, 2023Expiration Date Error; Expiration Date Error

  DISTRIBUTOR WAS NOTIFIED BY REPRESENTATIVE THAT THE BIMOBILE SHELL IMPLANTED ON (B)(6) 2023 HAD AN EXPIRATION DATE OF FEB. 2023. THE SHELL WAS THEN REMOVED AND REPLACED WITH A MOBILE LINK CLUSTER-HOLE IMPLANT INSTEAD, WITH A CHANGED OUT LINER IN ORDER TO CONVERT. [CUSTOMER].

  Patient problems: Insufficient Information

  MAUDE report 16973162 ↗

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