Anthology 71365601Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010559968), received between Sep 7, 2020 and Sep 8, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 reports).

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 18, 2026.

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.

• MalfunctionSep 8, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING PROCEDURE, THERE WAS AN ISSUE WITH THE IMPLANT SITTING HIGH AFTER BROACHING. PROCEDURE WAS CONCLUDED WITH THE SAME DEVICES, WITHOUT A DELAY OR AND INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10502986 ↗
• MalfunctionSep 8, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING PROCEDURE, THERE WAS AN ISSUE WITH THE IMPLANT SITTING HIGH AFTER BROACHING. PROCEDURE WAS CONCLUDED WITH THE SAME DEVICES, WITHOUT A DELAY OR AND INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10502909 ↗
• MalfunctionSep 7, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING PROCEDURE, THERE WAS AN ISSUE WITH THE IMPLANT SITTING HIGH AFTER BROACHING. PROCEDURE WAS CONCLUDED WITH THE SAME DEVICES, WITHOUT A DELAY OR AND INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10499571 ↗

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