Zero-P VA 03.647.963Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034720760), received between Apr 24, 2020 and Sep 25, 2026 — classified as 3 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Compatibility Problem

  It was reported while the implant was mounted on the implant holder, the holder was squeezed, according to the surgical technique. Then the knurled nut was turned on the thread to fix the position of the holder. Shortly before the nut was at the end position, it stopped turning and was jammed. It could no longer be loosened by hand. It did not come loose even with a clamp or forceps. A new implant had to be unpacked, which was then implanted with a clamp. The surgery could be completed successfully with a ten (10) minute delay and no harm to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899830 ↗
• MalfunctionMar 17, 2026Material Integrity Problem

  IT WAS REPORTED DURING PREPARATION, IT WAS FOUND THAT THE LOCKNUT DOES NOT ROTATE CORRECTLY. THE THREAD APPEARS TO BE DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617615 ↗
• MalfunctionApr 24, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, A POST-IMPLANTATION PROCEDURE WAS PERFORMED ON THE CAGE WITH CASPAR RESTRICTOR AND IMPLANT HOLDER. THE SURGEON WANTED TO REMOVE THE IMPLANT HOLDER FROM THE IMPLANT. WHILE DOING THIS, THE PLATE PART OF THE ZERO-P-VA REMAINED ON THE IMPLANT HOLDER AND THE PEEK PART REMAINED IN THE DISC POCKET. THE SURGEON WAS ABLE TO REMOVE THE PEEK-PART OF THE ZERO P VA WITH A PAIR OF TWEEZERS FROM THE DISC POCKET. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A DELAY OF THREE (3) MINUTES. NO ADVERSE PATIENT HARM WAS REPORTED. THIS REPORT IS FOR ONE (1) INSERTION DEVICE FOR ZERO-P VA. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9996224 ↗

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