ALTERA 1124.1111Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889095069679), received between Feb 29, 2024 and May 8, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (1 report).

1 FDA recall record name this device's identifier.

21 other recalls cover devices cleared under the same FDA submission (K140411); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 22, 2020Terminated

   Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

   Z-2858-2020 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Migration

  IT WAS REPORTED THAT AN ALTERA WAS INSERTED AT L5/S AND FIXED POSTERIORLY WITH COMPETITOR'S SCREW SYSTEM. THEN ON (B)(6) 2026 THE ALTERA WAS INSERTED AT L4/L5 DUE TO ADJACENT SEGMENT DISEASE. THEN ON (B)(6) 2026, DUE TO BACK OUT OF ALTERA INSERTED AT L4/5, IT WAS REMOVED FROM L4/5 AND A DIFFERENT CAGE WAS INSERTED INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25122784 ↗
• MalfunctionApr 15, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A SURGERY THE SPACER WAS NOT ABLE TO EXPAND, BUT WAS LEFT IN THE PATIENT POST OPERATIVELY. THIS EVENT OCCURRED IN JAPAN.

  Patient problems: Spinal Column Injury

  MAUDE report 19104493 ↗
• MalfunctionMar 5, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THERE WAS AN ISSUE REMOVING AN ALTERA SPACER DURING SURGERY, AND IT WAS LEFT IN THE PATIENT POST OPERATIVELY. THIS EVENT OCCURRED IN JAPAN.

  Patient problems: Failure of Implant

  MAUDE report 18837330 ↗
• MalfunctionFeb 29, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT AN ALTERA SPACER WAS LEFT IN THE PATIENT POST OPERATIVELY AFTER IT DID NOT EXPAND. THIS EVENT OCCURRED IN JAPAN.

  Patient problems: Failure of Implant

  MAUDE report 18811048 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140411. One submission often covers many models, so check the product and lot details in each record.

• Z-2857-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15
• Z-2868-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8
• Z-2860-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8
• Z-2851-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8
• Z-2854-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8
• Z-2850-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8 (sterile)
• Z-2852-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8
• Z-2871-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15
• Z-2870-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15
• Z-2869-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15
• Z-2866-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8
• Z-2863-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15
• Z-2861-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8
• Z-2865-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8
• Z-2853-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8

…and 6 more.