AXSOS 437330Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154395705), received between Dec 28, 2020 and Dec 28, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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.

• MalfunctionDec 28, 2020Fracture; Fracture

  "DETECTED PLATE FRACTURE IN THE REMOVAL PROCEDURE."

  Patient problems: Failure of Implant

  MAUDE report 11076939 ↗

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