NA 5461-01-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295174462), received between Aug 30, 2017 and Aug 30, 2017 — classified as 1 malfunction.

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

5 other recalls cover devices cleared under the same FDA submission (K800894); 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.

• MalfunctionAug 30, 2017Break; Break

  IT WAS REPORTED THAT THE INTRODUCER FOR THE CEMENT RESTRICTOR HAD SNAPPED WHERE THE THREADS ARE INTRODUCED INTO THE CEMENT RESTRICTOR. THE CEMENT RESTRICTOR WAS ALREADY PLACED IN THE PATIENT'S FEMUR. THE BROKEN TIP IS THREADED INTO THE RESTRICTOR AND NO WAY TO REMOVE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6831171 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K800894. One submission often covers many models, so check the product and lot details in each record.

• Z-1688-2011 · Jan 27, 2011 · Terminated
  DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 5, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the distal medullary cana
• Z-1686-2011 · Jan 27, 2011 · Terminated
  DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 1, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the distal medullary cana
• Z-1690-2011 · Jan 27, 2011 · Terminated
  DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 5, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the distal medullary can
• Z-1689-2011 · Jan 27, 2011 · Terminated
  DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 3, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the distal medullary can
• Z-1687-2011 · Jan 27, 2011 · Terminated
  DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 4, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the distal medullary cana