Zero-P VA 04.647.137SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034750811), received between May 23, 2019 and May 23, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CZECH REPUBLIC AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING A CERVICAL DISCECTOMY PROCEDURE FOR CERVICAL DEGENERATIVE DISC DISEASE, DURING INSERTING OF THE ZERO-P VARIABLE ANGLE (VA) CONVEX CAGE USING AN UNKNOWN MALLET, THE ZERO-P VA CONVEX CAGE FELL APART IN THE PROCESS OF IMPLANTATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE ALTERNATIVE IMPLANT. DUE TO AVAILABILITY OF THE SAME PRODUCT ON CONSIGNMENT STOCK, THERE WAS NO DELAY OCCURRED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN MALLET (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8637189 ↗

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