NA 202.208Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982143921), received between Oct 23, 2018 and Oct 23, 2018 — classified as 1 injury.

4 other recalls cover devices cleared under the same FDA submission (K033995, K050110, K111540, K113364); 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.

• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT INITIAL SURGERY ON (B)(6) 2018 TO TREAT AN ANKLE FRACTURE. X-RAY TAKEN ON AN UNKNOWN POSTOPERATIVE DATE REVEALED MALREDUCTION. THE INITIAL PLATE PLACEMENT PUT THE FIBULA IN VALGUS. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018 FOR A HARDWARE REMOVAL. THE PLATE WAS REMOVED, AND A 1/3 TUBULAR WAS USED FOR FINAL FIXATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 8MM. THIS IS REPORT 6 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7996583 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033995, K050110, K111540, K113364. One submission often covers many models, so check the product and lot details in each record.

• Z-2389-2016 · Jun 28, 2016 · Terminated
  Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone,
• Z-0323-2016 · Nov 2, 2015 · Terminated
  2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone frag
• Z-1274-2014 · Jan 7, 2014 · Terminated
  Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bon
• Z-2278-2013 · Mar 8, 2013 · Terminated
  Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults