ALTERA 1124.1011Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889095258356), received between Mar 5, 2024 and Feb 3, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Collapse” (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-2851-2020 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Collapse

  IT WAS REPORTED THAT AFTER THE ORIGINAL CASE ON (B)(6) 2024 THE SURGEON NOTICED THE ALTERA CAGE HAS COLLAPSED ON A FOLLOW UP ON (B)(6) 2025. THE IMPLANT REMAINS IN THE PATIENT. THIS EVENT OCCURRED IN THE UK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251343 ↗
• MalfunctionMar 5, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A SURGERY, WHILE THE SPACER WAS BEING REMOVED, THE DURA MATER WAS INJURED. THIS EVENT OCCURRED IN JAPAN.

  Patient problems: Nervous System Injury

  MAUDE report 18838132 ↗

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-2858-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8
• Z-2867-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8
• Z-2869-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15
• Z-2852-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8
• Z-2864-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15
• Z-2868-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8
• Z-2855-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15
• Z-2862-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15
• Z-2871-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15
• Z-2856-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15
• Z-2853-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8
• Z-2863-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15
• Z-2860-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8
• Z-2865-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8
• Z-2854-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8

…and 6 more.