RingLoc® Hip System 103538Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304004061), received between Jun 4, 2024 and Jun 4, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K082446, K912245, K971890, K990032, K991807); 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.

• MalfunctionJun 4, 2024Difficult to Insert; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19462070 ↗
• MalfunctionJun 4, 2024Difficult to Insert; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19462010 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082446, K912245, K971890, K990032, K991807. One submission often covers many models, so check the product and lot details in each record.

• Z-0621-2021 · Nov 25, 2020 · Terminated
  Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheu
• Z-0627-2021 · Nov 25, 2020 · Terminated
  RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthe
• Z-1086-2019 · Mar 1, 2019 · Terminated
  Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item Number: 103531 Product Usage: Accessory to total hip implant
• Z-1087-2019 · Mar 1, 2019 · Terminated
  Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip implant Item Number: 103533 Product Usage: Accessory to total hip implant
• Z-2135-2011 · Mar 10, 2011 · Terminated
  Low Profile Self-Tapping Bone Screw, 6.5 mm X 25 mm, Qty. 1, Biomet Orthopedics, 66 East Bell Drive, P.O. Box 587, Warsaw, IN 46581 USA. STERILE. To provide fixation of any acetab