Zero-P VA 04.647.135SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034750798), received between May 17, 2024 and May 17, 2024 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K112068); 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 18, 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.

• MalfunctionMay 17, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, AFTER DRILLING THE SCREW INTO THE SCREW HOLE OF THE CAGE, THE SCREW COULD NOT BE BACKED OUT AGAIN FOR ANGLE CORRECTION BECAUSE THE PLATE ON THE CAGE WAS STUCK. IT WILL NOT UNLOCK. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS IN STABLE CONDITION. THIS REPORT INVOLVES ONE (1) ZERO-P VA IMPLANT 5MM HEIGHT CONVEX-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339438 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112068. One submission often covers many models, so check the product and lot details in each record.

• Z-0455-2014 · Sep 30, 2013 · Terminated
  Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indica