AXSOS 437532Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154396252), received between Jan 15, 2019 and Jan 15, 2019 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K061012); 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.

• InjuryJan 15, 2019Appropriate Device Problem Term/Code Not Available

  ITS REPORTED BY THE ATTORNEY, THROUGH THE FILING OF A LAWSUIT, THAT THE PLAINTIFF UNDERWENT A LEFT TOTAL KNEE REPLACEMENT ON (B)(6) 2016 THAT REQUIRED REVISION ON (B)(6) 2017 DUE TO A NONUNION FEMORAL SHAFT FRACTURE.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8250121 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061012. One submission often covers many models, so check the product and lot details in each record.

• Z-1063-2009 · Nov 24, 2008 · Terminated
  AxSOS Torque Limiting Screwdriver, T8 1.5 Nm 3.0mm Locking Set. REF 702749. This product is non sterile. Distributed in the USA by Howmedica Osteonics Corp, Mahwah, NJ. The torqu
• Z-1062-2009 · Nov 24, 2008 · Terminated
  AxSOS T8 Screwdriver, 3.0mm Locking Set. REF 702746. This product is non sterile. Distributed in the USA by Howmedica Osteonics Corp, Mahwah, NJ. The screwdrivers of the AxSOS s