SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM SLM-20-140Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07540194002662), received between Jan 5, 2021 and Jan 5, 2021 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K143355); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2021Fracture; Fracture

  A SLIM ROD INSERTED INTO THE RIGHT ULNA OF A 6-YEAR-OLD PATIENT BROKE AT THE NONUNION SITE. THE NAIL WAS IMPLANTED ON (B)(6) 2019.

  Patient problems: Cancer; Nonunion/Delayed-union Bone Fracture

  MAUDE report 11117832 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143355. One submission often covers many models, so check the product and lot details in each record.

• Z-2278-2019 · May 29, 2019 · Terminated
  SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System