Catalyft PL Expandable Interbody System 6061001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000253547), received between Mar 12, 2026 and Mar 12, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanics Altered” (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 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.

• MalfunctionMar 12, 2026Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR TRANSFORAMINAL LUMBAR INTE RBODY FUSION (TLIF). IT WAS REPORTED THAT THE INJECT INSERTER WILL NOT THREAD INTO INNER SLEEVE PIECE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24577338 ↗

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