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ALTERA 1124.1213Recalls & reported problems

Globus Medical, Inc. · ALTERA Spacer, 10 x 36, 10-14mm, 8° · Class 2 · Implant

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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-2867-2020 · Root cause: Nonconforming Material/Component · FDA record ↗

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-2868-2020 · Jul 22, 2020 · Terminated
    ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8
  • Z-2858-2020 · Jul 22, 2020 · Terminated
    ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8
  • Z-2863-2020 · Jul 22, 2020 · Terminated
    ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15
  • Z-2852-2020 · Jul 22, 2020 · Terminated
    ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8
  • Z-2853-2020 · Jul 22, 2020 · Terminated
    ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8
  • Z-2850-2020 · Jul 22, 2020 · Terminated
    ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8 (sterile)
  • Z-2854-2020 · Jul 22, 2020 · Terminated
    ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8
  • Z-2871-2020 · Jul 22, 2020 · Terminated
    ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15
  • Z-2851-2020 · Jul 22, 2020 · Terminated
    ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8
  • Z-2856-2020 · Jul 22, 2020 · Terminated
    ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15
  • Z-2869-2020 · Jul 22, 2020 · Terminated
    ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15
  • Z-2855-2020 · Jul 22, 2020 · Terminated
    ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15
  • Z-2861-2020 · Jul 22, 2020 · Terminated
    ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8
  • Z-2866-2020 · Jul 22, 2020 · Terminated
    ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8
  • Z-2870-2020 · Jul 22, 2020 · Terminated
    ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15

…and 6 more.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.