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Regard NU00260HRecalls & reported problems

Roi Cps, LLC · Spine Pack · Class 1

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.

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. Oct 20, 2022Terminated

    Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

    Z-0289-2023 · Root cause: Component change control · FDA record ↗

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