BiMobileRecalls & reported problems across all models

We found 3 models of BiMobile by WALDEMAR LINK GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between May 22, 2023 and Sep 2, 2025 — classified as 3 injuries, 1 malfunction.

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

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

BiMobile 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. Jan 22, 2024Open, Classified

   Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery

   Z-1219-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported BiMobile problems

BiMobile models

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

• BiMobile 184-280/12

  Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
  1 recall1 report
• BiMobile 184-101/46

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  2 reports
• BiMobile 184-260/01

  Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
  1 report

Recent BiMobile adverse event reports

The 4 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 2, 2025Off-Label Use; Naturally Worn; Off-Label Use; Naturally Worn

  WEAR OF THE LINER.

  Patient problems: Pain

  MAUDE report 22936934 ↗
• MalfunctionJan 24, 2024Inaccurate Information; Inaccurate Information

  LABELING "F INSTEAD OF G".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18570366 ↗
• 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 ↗

Other WALDEMAR LINK GmbH & Co. KG products

• Unicondylar Sled Prosthesis48 models · 12 reports · 48 recalls
• Endo-Model Modular Knee Prosthesis System64 models · 57 reports · 12 recalls
• LinkSymphoKnee117 models · 79 reports · 11 recalls
• LINK Instrument14 models · 8 reports · 12 recalls
• Endo-Model SL Knee Prosthesis System25 models · 52 reports · 6 recalls
• Endo-Model Standard Knee Prosthesis System15 models · 19 reports · 6 recalls
• LINK Embrace Shoulder System Line Extension2 models · 1 reports · 4 recalls
• SPII Model Lubinus174 models · 6 reports · 3 recalls