SL-PLUS 75007309Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07611996076394), received between Apr 13, 2021 and Jun 16, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2022Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY, A PIECE OF THE SPRING DEVICE THAT ALLOWS THE ATTACHMENT OF SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 10MM BROKE OFF. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14711062 ↗
• MalfunctionMay 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT A SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 10MM WAS FOUND TO BE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14462433 ↗
• MalfunctionOct 8, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 10MM WAS FOUND TO HAVE THE TIP BROKEN OFF. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12599248 ↗
• MalfunctionApr 13, 2021Fracture; Fracture

  IT WAS REPORTED THAT WHEN ATTACHING THE FIRST BROACH TO THE BROACH HANDLE, THE BROACH FELL OFF THE OF THE HANDLE. THEN, IT WAS NOTICED THAT THE LOCKING MECHANISM WAS BROKEN. THE OFFSET BROACH HANDLE WAS USED INSTEAD WITH NO ADVERSE CONSEQUENCES. THIS WAS NOTICED DURING SET UP/INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11654378 ↗

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