R3 71360752Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010599056), received between Apr 11, 2021 and May 23, 2022 — classified as 2 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K123598); 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.

• MalfunctionMay 23, 2022Break; Break

  IT WAS REPORTED THAT, THE THREADS OF AN R3 ACET TRIAL SHELL 52MM ARE BROKEN. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14480411 ↗
• MalfunctionApr 11, 2021Material Fragmentation; Material Fragmentation

  I WAS REPORTED THAT THE R3 ACET TRIAL SHELL 52MM WAS EXPERIENCING SOME METAL SHAVING ON THE THREADING. INCIDENT OCCURRED DURING SERVICE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646939 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2019 · Jan 7, 2019 · Terminated
  SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
• Z-1008-2017 · Nov 16, 2016 · Terminated
  REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116