NA 04.005.418SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982085313), received between Nov 24, 2021 and Nov 24, 2021 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K000089, K103002); 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.

• InjuryNov 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION SURGERY DUE TO IMPLANTS USED CAUSING THE PATIENT TO LOSE REDUCTION OF THE BONE. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 28MM F/IM NAILS-STER. THIS IS REPORT 3 OF 5 FOR (B)(4)

  Patient problems: Physical Asymmetry

  MAUDE report 12869404 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000089, K103002. One submission often covers many models, so check the product and lot details in each record.

• Z-2060-2012 · May 22, 2012 · Terminated
  4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Mu
• Z-2059-2012 · May 22, 2012 · Terminated
  4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Mu