Catalyft PL Expandable Interbody System NAV6061000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000255237), received between Jul 4, 2025 and Jul 4, 2025 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K210425, K214011); 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.

• MalfunctionJul 4, 2025Device Handling Problem; Device Handling Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT PRODUCT WAS INITIALLY VERIFIED BEFORE THE CASE. DURING THE PROCEDURE, THE INSERTER WAS REMOVED FROM THE TOOL CARD AND THEN LATER ADDED BACK. ONCE ADDED BACK THE INSTRUMENT NEEDED TO BE REVERIFIED WHILE THE NAVIGATION FRAME WAS ATTACHED TO THE PATIENT. THEY WERE UNABLE TO VERIFY THE INSTRUMENT WITH THE NAVIGATIONVERIFICATION TOOL INSERTED. THEY THEN GRABBED OUR SECOND CATALYFT NAVIGATION INSTRUMENTS SET AND WE¿RE THEN ABLE TO VERIFY THE SECOND INSERTER. THE INSERTER WAS FOUND TO BE INTACT, WITH NO SIGNS OF FRACTURE, STRIPPING, BENDING, OR OTHER DAMAGE. SUBSEQUENT TESTING AND USE OF THE INSERTER REVEALED NO ISSUES. BASED ON THESE FINDINGS, THE ISSUE APPEARS TO BE RELATED TO DEVICE HANDLING RATHER THAN AN INSERTER MALFUNCTION. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22403434 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K210425, K214011. One submission often covers many models, so check the product and lot details in each record.

• Z-0580-2026 · Sep 16, 2025 · Open, Classified
  Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073. 2. SPACER 6068