EXETER 0939-0-116Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540167248), received between Jan 30, 2017 and Jan 30, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K173499, K191414, K980843); 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.

• MalfunctionJan 30, 2017Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  STRYKER SALES REPRESENTATIVE REPORTED THAT 2 CEMENT RESTRICTORS BROKE DURING INSERTION. THE FIRST TIME THE RESTRICTOR SPLIT, THE SURGEON HAD TO MANUALLY REMOVE EACH OF THE PIECES. THESE WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THE SECOND TIME, ON ADVICE FROM SENIOR SURGEON, HE OPTED TO LEAVE THE RESTRICTOR IN. THE TOP BROKE OFF THIS PARTICULAR ONE BUT IT WAS SO WELL FIXED IT WAS PROVING DIFFICULT TO REMOVE. TWO DIFFERENT INTRODUCERS WERE USED. THESE HAVE BEEN USED WITHOUT ISSUE IN PREVIOUS SURGERIES.

  Patient problems: No Information

  MAUDE report 6287305 ↗
• MalfunctionJan 30, 2017Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  THE STRYKER SALES REPRESENTATIVE REPORTED THAT 2 CEMENT RESTRICTORS BROKE DURING INSERTION. THE FIRST TIME THE RESTRICTOR SPLIT, THE SURGEON HAD TO MANUALLY REMOVE EACH OF THE PIECES. THESE WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THE SECOND TIME, ON ADVICE FROM SENIOR SURGEON, HE OPTED TO LEAVE THE RESTRICTOR IN. THE TOP BROKE OFF THIS PARTICULAR ONE BUT IT WAS SO WELL FIXED IT WAS PROVING DIFFICULT TO REMOVE. TWO DIFFERENT INTRODUCERS WERE USED. THESE HAVE BEEN USED WITHOUT ISSUE IN PREVIOUS SURGERIES

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 6287297 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173499, K191414, K980843. One submission often covers many models, so check the product and lot details in each record.

• Z-0313-2022 · Oct 15, 2021 · Open, Classified
  28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
• Z-0314-2022 · Oct 15, 2021 · Open, Classified
  28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122