SL-PLUS 75007255Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07611996065343), received between Mar 3, 2025 and Mar 3, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2025Crack; Fracture; Crack; Fracture

  IT WAS REPORTED THAT, DURING THA SURGERY, THE PART OF THE ROD ON ONE (1) SL-PLUS STEM IMPACTOR, CRACKED WHILE IN USE AND BROKE. THE PIECE DID NOT FALL INSIDE THE PATIENT. THE SURGERY WAS COMPLETED, BUT IT IS UNKNOWN HOW, WITHOUT ANY DELAY. NO INJURIES WERE REPORTED. THE PIECE WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21505225 ↗

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