Catalyft PL Expandable Interbody System 6061000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000253530), received between Aug 16, 2021 and Mar 12, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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

• MalfunctionMar 12, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE TEETH BROKE OFF THE TIP. 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 24578001 ↗
• MalfunctionMar 11, 2026Break

  INFORMATION WAS RECEIVED FROM REGULATORY BODY (RB), USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR TLIF INTERBODY INSERTION SPINAL THERAPY. IT WAS REPORTED THAT DEVICE WAS RUSTED AND BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT INNER PORTION OF THE INSERTER HAS RUSTED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569340 ↗
• InjuryAug 16, 2021Device Slipped; Mechanical Jam; Device Slipped; Mechanical Jam

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH UNKNOWN INDICATION FOR SPINAL THERAPY. IT WAS REPORTED THAT WHEN USING THE CATALYFT PL DEVICE ON A CASE AND AFTER THE DEVICE HAD BEEN IMPLANTED AND WAS BEING BACKFILLED WITH AUTOGRAPH BONE VIA THE FUNNEL (THAT SCREWS INTO THE INSERTER) BECAME JAMMED. IT WAS SKIVED OFF AND THE AGGRESSIVE DISTAL POINT CAUSED A DURA INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PRE-OP DIAGNOSIS WAS LUMBAR STENOSIS AND THE PROCEDURE INVOLVED WAS POSTERIOR LUMBAR INTERBODY FUSION. PRODUCT CAME IN CONTACT WITH THE PATIENT. AFTER IMPLANTATION OF THE IMPLANT, PER THE SURGICAL TECHNIQUE, THE SURGEON REMOVED THE INNER PORTION OF THE INSERTER, SCREWED ON THE BONE FUNNEL PORTION AND BEGAN TO PLUNGE THE AUTOGENOUS BONE GRAFT THROUGH THE INSERTER WITH THE GRAFT TAMP. WHILE PLUNGING THE BONE, THE INSERTER SLIPS OFF OF THE IMPLANT AND HE SAYS IT TORE THE DURA. THERE WAS AN ADDITIONAL MEDICAL INTERVENTION DONE AS A RESULT OF THIS. SURGEON SUTURED THE DURA FOR REPAIR, AND APPLIED A DURA SEALANT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE INSERTER HASN¿

  Patient problems: Spinal Cord Injury

  MAUDE report 12323757 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K210425. 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