MULTILOC 04.019.028Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982089700), received between Sep 29, 2020 and Sep 29, 2020 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (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.

• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A REVISION SURGERY OCCURRED DUE TO FRACTURE DISPLACEMENT AND IMPAIRED HEALING. NO IMPLANT MALFUNCTIONS OCCURRED. ALL HARDWARE WAS REMOVED. IT IS UNKNOWN WHAT IMPLANTS THE PATIENT WAS REVISED TO. THE ORIGINAL SURGERY AND IMPLANTATION WITH THE MULTILOC HUMERAL NAILING SYSTEM OCCURRED ON (B)(6) 2020. THE PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 10600460 ↗

Recalls under the same FDA submission

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

• 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
• 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