NA 458.850Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982230393), received between Aug 7, 2018 and Aug 7, 2018 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K000089, K040762); 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. How this data works · Data updated Oct 13, 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.

• InjuryAug 7, 2018Adverse Event Without Identified Device or Use Problem

  THE REMOVAL SURGERY SCHEDULED FOR (B)(6) 2018 HAS BEEN CANCELED. REMOVAL SURGERY WILL TAKE PLACE, BUT THE RESCHEDULED DATE IS AS YET UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 7758281 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000089, K040762. One submission often covers many models, so check the product and lot details in each record.

• Z-2051-2015 · Jun 3, 2015 · Terminated
  TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal
• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.