FREE GLIDING SCFE SCREW SYSTEM SCF-T65-48S/50LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07540194002266), received between Aug 26, 2022 and Aug 26, 2022 — classified as 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K131591); 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.

• MalfunctionAug 26, 2022Wrong Label; Wrong Label

  DURING THE REPLENISHMENT OF A TRAY BY THE DISTRIBUTOR, THE BOX LABELED FOR A SCF-T65-48S/50L COMPONENT WAS FOUND WITH A SCF- M73-L COMPONENT INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15304925 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131591. One submission often covers many models, so check the product and lot details in each record.

• Z-0324-2016 · Oct 20, 2015 · Terminated
  SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System i
• Z-1848-2015 · Jun 15, 2015 · Terminated
  Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.