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Regard™ OR01100ARecalls & reported problems

Roi Cps, LLC · SPINE PACK · Class 1

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

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

2 FDA recall records name this device's identifier, 1 still open.

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. Mar 22, 2023Open, Classified

    The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

    Z-1438-2023 · Root cause: Nonconforming Material/Component · FDA record ↗

  2. Oct 20, 2022Terminated

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

    Z-0321-2023 · Root cause: Component change control · FDA record ↗

Other Orthopedic Tray devices

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