RINGLOC HIP SYSTEM 14-103654Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304229891), received between Dec 15, 2020 and Dec 15, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K030055, K921301); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2020Fracture; No Apparent Adverse Event; Insufficient Device Problem Information; Fracture; No Apparent Adverse Event; Insufficient Device Problem Information

  ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tissue Damage

  MAUDE report 11013827 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030055, K921301. One submission often covers many models, so check the product and lot details in each record.

• Z-0523-2020 · Aug 21, 2019 · Terminated
  Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-103204 21-103205 21-103206 21-103207 21-103208 21-10320
• Z-1754-2015 · Apr 16, 2015 · Terminated
  Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral
• Z-1122-2015 · Jan 9, 2015 · Terminated
  Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)