REGENEREX RINGLOC + HIP SYSTEM PT-116056Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304451438), received between Jan 20, 2020 and Jan 20, 2020 — classified as 1 injury.

19 other recalls cover devices cleared under the same FDA submission (K070369); 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.

• InjuryJan 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Extraskeletal ossification; Pain; Scar Tissue; Unspecified Infection

  MAUDE report 9608252 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070369. One submission often covers many models, so check the product and lot details in each record.

• Z-2453-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 54 mm Size 23, with Lock Ring, sterile, REF PT-106054, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is
• Z-2456-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 62 mm Size 25, with Lock Ring, sterile, REF PT-106062, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is
• Z-2458-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 66 mm Size 26, with Lock Ring, sterile, REF PT-106066, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is
• Z-2452-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 64 mm Size 26, w/Lock Ring w/Plug, sterile, REF PT-104064, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenere
• Z-2462-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 50 mm Size 22, with Locking Ring, sterile, REF PT-116050, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringl
• Z-2449-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 52 mm Size 23, w/Lock Ring w/Plug, sterile, REF PT-104052, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenere
• Z-2461-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 48 mm Size 22, with Locking Ring, sterile, REF PT-116048, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ring
• Z-2464-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 54 mm Size 23, with Locking Ring, sterile, REF PT-116054, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ring
• Z-2448-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 50 mm Size 22, w/Lock Ring w/Plug, sterile, REF PT-104050, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous
• Z-2460-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 74 mm Size 28, with Lock Ring, sterile, REF PT-106074, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is
• Z-2451-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 62 mm Size 25, w/Lock Ring w/Plug, sterile, REF PT-104062, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenere
• Z-2466-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 60 mm Size 25, with Locking Ring, sterile, REF PT-116060, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ring
• Z-2457-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 64 mm Size 25, with Lock Ring, sterile, REF PT-106064, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is
• Z-2455-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 60 mm Size 25, with Lock Ring, sterile, REF PT-106060, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is
• Z-2459-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 70 mm Size 27, with Lock Ring, sterile, REF PT-106070, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is

…and 4 more.