RINGLOC BI-POLAR HIP SYSTEM 11-165206Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304001923), received between Jan 6, 2022 and Nov 19, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

2 FDA recall records name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K051569, K833175); 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.

Recalls naming this device

1. May 17, 2024Class IIOpen, Classified

   41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention

   Z-2179-2024 · Root cause: Labeling mix-ups · Recall details · FDA record ↗

2. Sep 3, 2020Class IITerminated

   Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization.

   Z-0097-2021 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Joint Dislocation

  MAUDE report 23592975 ↗
• MalfunctionNov 6, 2025Positioning Failure; Positioning Failure

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23491002 ↗
• MalfunctionJan 6, 2022Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN INITIAL HIP ARTHROPLASTY, IT WAS FOUND THAT THE METAL RING OF THE BIPOLAR CUP WAS BENT OUTWARDLY AND THE LINER WOULD NOT SEAT INTO THE CUP. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13181351 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051569, K833175. One submission often covers many models, so check the product and lot details in each record.

• Z-0628-2021 · Nov 25, 2020 · Terminated
  RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phospha
• Z-1860-2017 · Feb 17, 2017 · Terminated
  various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option Head E1 RingLoc Bi-Polar Freedom Constr