NA 04.005.644Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982086761), received between Feb 18, 2021 and Feb 18, 2021 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K970733); 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.

• InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF ONE (1) TI CANNULATED ANTEGRADE FEMORAL NAIL AND THREE (3) LOCKING SCREW ON (B)(6) 2021, DUE TO NONUNION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11343110 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K970733. One submission often covers many models, so check the product and lot details in each record.

• Z-2243-2013 · Apr 18, 2013 · Terminated
  Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.