NA 04.003.030SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982081643), received between Jun 13, 2018 and Sep 15, 2022 — classified as 3 injuries.

2 other recalls cover devices cleared under the same FDA submission (K040336, K172157); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 ALL IMPLANTS REMOVED WITHOUT INCIDENT. PATIENT WAS INFECTED. CLEAN OUT CANAL THROUGH REAMING AND IRRIGATION. IMPLANT OF AN ANTIBIOTIC COATED NAIL. NO IMPLANTS TO BE RETURNED. THIS REPORT IS FOR ONE (1) 6.5 TI RECON SCREW T25 SD 100-STERILE. THIS IS REPORT 4 OF 11 FOR COMPLAINT.

  Patient problems: Unspecified Infection

  MAUDE report 15429241 ↗
• InjuryJun 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART#UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10214411 ↗
• InjuryJun 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR ON (B)(6) 2017. THE PATIENT UNDERWENT REMOVAL OF ONE (1) 10MM TITANIUM LATERAL FEMORAL RECON NAIL, ONE (1) 5.0MM TITANIUM LOCKING SCREW WITH T25 STARDRIVE 48MM, ONE (1) 5.0MM TITANIUM LOCKING SCREW WITH T25 STARDRIVE 54MM AND TWO (2) 6.5MM TITANIUM RECON SCREW WITH T25 STARDRIVE 100MM ON (B)(6) 2018 DUE TO POST-OPERATIVE PAIN. ALL THE HARDWARE WAS REMOVED INTACT. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS STABLE. THIS REPORT IS FOR ONE (1) 6.5MM RECON SCREW 100MM. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7598534 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040336, K172157. One submission often covers many models, so check the product and lot details in each record.

• Z-1915-2015 · May 27, 2015 · Terminated
  DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Sub
• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.